Bridge™ Prep Kit 00884450294819Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450294819), received between Jul 23, 2020 and Jan 7, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT A (B)(6)-YEAR-OLD FEMALE PATIENT ON DIALYSIS, PRESENTED AT (B)(6) HOSPITAL, (B)(6), ON (B)(6) 2020 WITH A RECURRENT BACTEREMIA INFECTION. THE PATIENT WAS IMPLANTED WITH A ST. JUDE 7120, DUAL-COIL ICD LEAD ON (B)(6) 2013. THE PHYSICIAN BEGAN THE CASE BY GAINING VENOUS ACCESS IN THE LEFT FEMORAL VEIN WITH THE 12F SHEATH INCLUDED IN THE OCCLUSION BALLOON. (THE RIGHT FEMORAL VEIN WAS OCCLUDED DUE TO A DIALYSIS CATHETER) AND THEN ADVANCED THE GUIDEWIRE THROUGH THE SHEATH AND INTO THE IVC AND ON THROUGH TO THE SVC. IT WAS APPARENT THAT THERE WAS SIGNIFICANT CALCIFICATION [DISEASE] WITHIN THE SVC AND AROUND THE SVC LEADS COIL. THE GUIDEWIRE INITIALLY WOULD NOT ADVANCE PAST THE MID-SVC AFTER SEVERAL ATTEMPTS. THE PHYSICIAN LOADED AN OCCLUSION BALLOON ONTO THE WIRE AND ADVANCED IT TO THE AREA OF STALLED PROGRESSION [MID SVC]. THE BALLOON SERVED AS SUPPORT FOR THE WIRE AND WAS SUFFICIENT THAT THE WIRE FINALLY FOUND A CHANNEL TO ADVANCE THROUGH. ACCESS WAS COMPLETED AT THE RIGHT SUBCLAVIAN VEIN, WHERE THE PHYSICIAN WAS ABLE TO ADVANCE AND FINALLY ANCHOR THE GUIDEWIRE AND THE OCCLUSION BALLOON INTO POSITION AT THE RA/SVC JUNCTION. A PRE-INFLATION WITH APPROXIMATELY 10C

  Patient problems: Perforation; Perforation of Vessels

  MAUDE report 11135954 ↗
• MalfunctionJul 23, 2020Malposition of Device; Malposition of Device

  THE ACCOUNT ALLEGES THAT DURING A SUCCESSFUL LEAD EXTRACTION PROCEUDRE, THE PATIENT WAS STABLE AND THE POCKET WAS CLOSED. WHEN THE 12F INTRODUCER SHEATH WAS REMOVED FROM THE GROIN AFTER THE PROCEDURE, BLEEDING WAS NOTICED IN THE AREA. VASCULAR SURGEON DISCOVERED AN INJURY IN THE RIGHT COMMON ILIAC ARTERY. THE ACCOUNT ALLEGES THAT THE NEEDLE CONTAINED WITHIN THE BRIDGE ACCESSORY KIT PUNCTURED BOTH THE FEMORAL VEIN AND THE ARTERY DURING PREPARATION FOR PROPHYLACTIC STAGING OF THE BRIDGE BALLOON PRIOR TO THE CASE, AND THAT THE 12F INTRODUCER SHEATH PROVIDED TAMPONADE TO THE INJURY DURING THE ACTUAL PROCEDURE. ONLY AFTER THE 12F INTRODUCER SHEATH WAS REMOVED WAS THE INJURY DETECTED. IT HAS BEEN REPORTED THAT THE RIGHT COMMON ILIAC ARTERY WAS STENTED AND THE PATIENT SURVIVED THE PROCEDURE. THERE WAS NO ALLEGED MALFUNCTION OF THE BRIDGE BALLOON, NOR DID THE BRIDGE BALLOON ITSELF CONTRIBUTE TO A SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10317257 ↗