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Medical litter: Device debris poses serious risk

LaCheryl Robinson of Pontiac, Mich., endured nearly eight years of unexplained pain following a breast biopsy until a lump appeared last January and a new mammogram showed the source of the trouble: a broken needle embedded in her left breast.

And Lisa Schweska, a teacher from Springfield, Ill., missed most of last year with her third-grade class while doctors grappled with a metal blood-clot filter that shifted, pierced a vein and couldn’t be removed.

“They said, ‘It could be just fine, or it could puncture your duodenum,’” said Schweska, 40. “I said, ‘I have three kids; I can’t wait for that to happen.’”

The three women are among hundreds of patients who have learned the hard way about a growing but under-recognized problem: medical devices that break or malfunction, leaving behind potentially deadly debris.

Earlier this year, federal Food and Drug Administration officials warned clinicians about the danger of devices that litter patients’ bodies with broken stents, torn balloons, fractured wires and stray parts ranging from catheter tips to drill bits.

“Patients who harbor such material may subsequently experience complications such as local tissue rejection, inflammation, perforation, blood vessel obstruction and death,” is how the Journal of the American Medical Association recently summarized the problem in a cautionary article.

Even worse, some health workers don’t tell their patients about the broken devices, sending them home with pieces that have the potential to migrate throughout the body, or to interact with future procedures such as magnetic resonance imaging.  One worry is that metal objects can overheat during MRIs, scorching patients from the inside.  

Robert A. Fischer, an FDA nurse consultant who reviews adverse events, said he issued the public health notification after two years of informal reports showed problems involving more than 200 medical devices.

“We decided that the best way to approach this was to say: ‘This is a problem and be careful,’” Fischer said.

More than 70 deaths, nearly 4,700 injuries

Since 2003, reports of 72 deaths and 4,675 injuries associated with “unretrieved device fragments,” or UDFs, have been logged in the FDA database that tracks adverse events.

The FDA reports likely underestimate the magnitude of the problem, said Dr. Mark Estes, president of the Heart Rhythm Society, a research and advocacy agency that has pushed for better enforcement of cardiac device standards.

“The monitoring system is a passive system,” Estes said. “The FDA accepts what comes in from doctors and manufacturers. There is tremendous under-reporting of devices.”

The most common problem occurs when wire guides for catheters used in heart operations break or fracture, leaving the device or fragments behind, an analysis shows. Bone screws used in orthopedic operations are often culprits as well.

The incidence of UDFs is probably on par with mistakes that have received far more attention: sponges and instruments left behind after surgery, said Dr. John R. Clarke, medical director of the ECRI Institute, a patient safety and research agency in Pennsylvania.

Those objects are inadvertently left behind in perhaps 1 of every 1,000 to 1,500 abdominal operations, according to a 2003 estimate. UDFs are different, however, because doctors usually know they're there, but they either make no attempt to retrieve the devices or are unsuccessful when they try.

“In some cases, finding a 10/0 [gauge] needle would be like looking for a contact lens in a shag rug carpet,” Clarke said. “Or, you know exactly where it is, but medically retrieving it would not be worth the risk. You’re not going to dig apart the femur to get a quarter-inch screw.”

‘What if it breaks again and kills me?’

For patients left with the devices, that argument poses a dilemma. Katherine Ellsworth, 57, a property insurance administrator from Lansing, Mich., nearly died last year after a 1 1/2-inch spike broke off a filter inside her abdomen and pierced the right ventricle of her heart. Doctors recovered the fragment and repaired her heart, but decided to leave the rest of the filter behind.

“The fear now that I live with is ‘What if it breaks again and kills me?’” she said. “You kind of live with that in the back of your mind.”

Devices can break for a variety of reasons ranging from significant manufacturing defects to gross operator error, according to a review of FDA reports of adverse events.

But other factors also contribute: Improperly stored catheters that have been exposed to light, for instance, can become brittle over time, increasing the chance of fracture, records show. Or doctors may be forced to use slightly unfamiliar devices or tools when vendors switch styles without notice, Clarke noted.

Whatever the cause, it's the patient who suffers. In one case, reported on Nov. 18, 2004, a balloon catheter failed to inflate inside a man’s ureter. Doctors were forced to cut away the balloon, leaving the device inside the man’s penis with a portion extending from the tip. The balloon remained for six days before it was removed.

Several reports described doctors using too much force to insert or remove certain devices in failing patients.  

“The physician tried to pull and push, but was not successful,” read a summary from April 26, 2007. “The guide wire broke in two pieces inside the micro-catheter; at the same time, the stent broke in two.”

In that case, a piece of stent remained inside the patient, who developed swelling inside the brain and a blood clot in an artery — and subsequently died.

“When you're getting frustrated, sometimes the practitioner won't use the same judgment they would if they weren't having a frustrating moment,” Fischer said.

Patients don't know devices are there

The biggest problem is not just that the devices break, or that doctors decide to leave them behind, but that doctors often don't tell their patients about the problem, according to case studies, Fischer said. Some may not want to worry their patients unnecessarily, while others may fear legal consequences.

Those are not good enough reasons to keep patients in the dark, said Clarke, who stresses the need for transparency.

“They should know and be told whether to expect any problem with it,” he said. “Nobody likes surprises.”

People who’ve had devices left behind say not knowing is the worst part.

LaCheryl Robinson, for instance, is convinced that the technician who performed a breast biopsy in April 2000 knew that the needle broke during the procedure. She’s angry that doctors discounted her symptoms and feelings until the lump appeared last winter.

“The radiologist said, ‘Oh my God, there’s a needle in your breast,’” recalled Robinson, 50, who works two jobs — as a machine operator and for a beer distributor — and cares for her ailing mother. “I thought, ‘Oh my God, at least it’s not cancer.”

“It’s still not fair,” she said. “That was eight years of suffering and not knowing.”

Representatives for POH Medical Center in Pontiac declined comment on Robinson’s case because of pending litigation.

In Pamela Jones’ case, the scalpel blade wasn’t detected until 12 years after Dr. Jeffrey D. Sabloff performed surgery in 1991 on her chronically inflamed kneecap.

Between 1991 and 2003, Jones complained of pain in her thigh, court records show. Sabloff's associates at Greater Metropolitan Orthopaedics in Waldorf, Md., continued to treat her, never discovering the blade. Another doctor diagnosed psoriatic arthritis and placed Jones on powerful drugs.

Finally, in 2003, her knee became even more painful and developed a tender mass. Suspecting cancer, a doctor ordered an MRI, but the procedure caused excruciating pain, prompting a technician to order an X-ray.

‘You've got a blade in your leg’

“He came back into the room and he had this God-awful look on his face,” recalled Jones, 44, a high school culinary arts teacher. “He said ‘You’ve got a blade in your leg.’ At that point, my heart sunk into my stomach.’”

Surgery fixed the problem, but Jones still regrets spending so long in pain and on drugs. “It almost stopped everything I enjoyed for all those years,” she said.

A representative for Sabloff said he was out of the country and couldn’t comment. Jones’ lawyer said she couldn’t discuss details of the final outcome other than to say the case had been resolved.

For Lisa Schweska, the teacher in Springfield, Ill., developing a blood clot in her leg, a deep vein thrombosis, seemed bad enough in November 2006. But the real trouble was with the metal filter designed to keep the clot from breaking apart and traveling to her lungs.

Medical records indicate a doctor nudged the device out of place while trying to remove the clots, Schweska said. It shifted, piercing her vena cava and threatening to rupture the vein that leads to the heart.

Two doctors tried, but failed, to remove the filter. Many doctors would have left the faulty device in place, but that would have been too dangerous, said Dr. Robert B. McLafferty, the surgeon who finally removed it in pieces in an unusual abdominal surgery in May 2007 that left Schweska with an 11-inch scar.

“I’ve taken out a number of filters that were tilted and this was the worst I’ve ever seen,” said McLafferty, a professor of medicine at the Southern Illinois School of Medicine. “This was a 39-year-old mother of three who could die.”

Schweska said she’s considering legal action against doctors at Prairie Heart Institute in Springfield who may have knocked the filter out of place without telling her. Until she insisted on seeing McLafferty, no one outlined a solution to the problem that caused her pain and cost her time with her family and students.

“I wish there would be some way that people would stop and think how they’re treating their patients,” she said.

Prairie Heart officials declined to comment on Schweska’s claims.

Better reporting, patient empowerment key

Tackling the issue of UDFs will require recognizing broken devices and fragments as problems as serious as any of the adverse events now used as measures for patient safety and performance.

Because it's a new concern with such sketchy reporting, it hasn't been added to the recognized list of preventable errors monitored by doctors and hospitals across the country.

“It would be very possible to develop a system in which UDFs would be reported,” said Estes.

In the meantime, it’s up to patients to protect themselves, said Lisa Salberg, president of the Hypertrophic Cardiomyopathy Association, a patient advocacy group.

“I have three cardiac leads in my chest right now,” said Salberg, who has never had problems with device fragments. “Yes, it’s an organizational issue, but it’s also a personal issue.”

Patients should ask doctors to explain potential complications of medical procedures and devices well before surgery begins. If a device is being removed, they should ask to see it. Afterward, they should ask if anything was left behind, Salberg said.

“We just need patients — that is, everybody — to know that while the medical community provides an amazing service to us all, it is still just a service industry,” she said. “It’s OK to ask questions."