Medical litter: Device debris poses serious risk

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."

More about medical devices FDA database offers insight Medical providers and device manufacturers report problems to the federal Food and Drug Administration, where they're tracked in the Manufacturer and User Facility Device Experience Database, known as MAUDE. Information about deaths, injuries and malfunctions associated with specific devices is available from July 31, 1996 through the present. The database is updated regularly.   To use the online search, click on the link below, fill in the appropriate information and click search. Specific requests yield targeted results. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm

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