TrapLiner™ catheter 5566Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI M20655660), received between Mar 7, 2017 and Nov 20, 2018 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  PHYSICIAN ACCESSED FEMORAL ARTERY. THE TRAPLINER BECAME DETACHED AT THE BALLOON DURING A PCI PROCEDURE. DEVICE WAS REMOVED IN ITS ENTIRETY; SNARED CABLE AND REMOVED. NO DELAY REPORTED, ALSO, NO COMPLICATIONS REPORTED. IT'S REPORTED AS NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8091235 ↗
• MalfunctionJul 13, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  PRIOR TO USE ON A PATIENT, (PRE-TESTING) TRAPLINER SEPARATED AT TRANSITION FROM HYPO TUBE TO LUMEN PRIOR TO ATTEMPTING TO ADVANCE IT ONTO THE WIRE AND INTO THE GUIDE. PROCEDURE COMPLETED SUCCESSFULLY, AND PATIENT IS FINE. THE PROCEDURE WAS COMPLETED WITH A NEW TRAPLINER. THE DEVICE WAS NEVER ADVANCED ON THE WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7685335 ↗
• MalfunctionJun 6, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  DURING THE MIDDLE OF THE PROCEDURE AND WHEN REMOVING FROM THE GUIDE IT CAME APART. THE PUSH ROD CAME APART AT THE WELD CONNECTING THE PUSH ROD TO THE DISTAL LUMEN. IT CAME APART AS IT WAS EXITING THE GUIDE CATHETER. NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6615531 ↗
• InjuryMay 3, 2017Detachment Of Device Component; Detachment Of Device Component

  INTERVENTION OF A LESION AT THE ANASTOMOSIS OF THE LIMA TO THE LAD. THE TRAPLINER BROKE IN THE BODY AT THE CONNECTION OF THE PUSH ROD TO THE HALF PIPE. BOTH PARTS OF THE TRAPLINER WERE REMOVED WITHOUT PATIENT IMPACT. PARTS WERE REMOVED BY INSERTING A BALLOON AND PULLED PARTS OUT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6541344 ↗
• MalfunctionMar 7, 2017Detachment Of Device Component; Detachment of Device or Device Component; Detachment Of Device Component; Detachment of Device or Device Component

  THE OPERATOR FORGOT TO REMOVE THE PTCA TRAPPING BALLOON FROM THE 8F GUIDE CATHETER PRIOR TO DELIVERING THE TRAPLINER. THE TRAPLINER SHAFT BROKE DURING THE ATTEMPT TO DELIVER IT INTO THE GUIDE CATHETER. THE PTCA BALLOON WAS REMOVED FROM THE GUIDE AND THE TRAPLINER WAS THEN DELIVERED INTO THE RCA, HOWEVER THE BALLOON WOULDN'T HOLD PRESSURE. WHEN THE TRAPLINER WAS REMOVED FROM THE GUIDE, IT SEPARATED INTO TWO PIECES. THE SEPARATION OCCURRED BETWEEN THE BALLOON AND THE HALFPIPE. REPORTED NO PATIENT INJURY OR IMPACT WITH THE TRAPLINER AND BOTH PIECES OF THE DEVICE WERE PULLED OUT FROM THE GUIDE. THE DOCTOR FORGOT TO TAKE A TRAPPING BALLOON OUT OF THE GUIDE PRIOR TO INSERTING TRAPLINER. BECAUSE THERE WAS NO ROOM WITHIN THE GUIDE, THE TRAPLINER WAS ADVANCED AGAINST RESISTANCE AND THE HYPO TUBE BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6383527 ↗