BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 1184473 · Received October 2, 2008

    Report

    Report Number
    9710478-2008-00132
    Event Type
    Injury
    Date Received
    October 2, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 11, 2008
    Manufacturer
    ABBOTT VASCULAR SWITZERLAND
    Product Code
    LIT
    PMA / PMN Number
    K062843
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABSOLUTE STENT (PART 1010558-80, LOT 7110951) IS BEING FILED ON A SEPARATE MEDWATCH. THE DEVICE WAS NOT RETURNED. WITHOUT THE DEVICE TO EXAMINE, A ROOT CAUSE COULD NOT BE DETERMINED. REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITY WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: BALLOON RUPTURE, CATHETER TIP DETACHMENT. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: ARTERIAL RUPTURE, CARDIAC ARREST, SURGICAL ARTERIAL REPAIR AND RETRIEVAL OF DETACHED DEVICES. IT WAS REPORTED THAT AN ABSOLUTE STENT WAS SUCCESSFULLY IMPLANTED IN THE LEFT ILIAC ARTERY. DURING POST-DILATATION, A FOX PLUS BALLOON RUPTURED CLOSE TO 20 ATMOSPHERES, ABOVE RATED BURST PRESSURE, DURING THE SECOND INFLATION. RESISTANCE WAS MET DURING REMOVAL OF THE BALLOON CATHETER. AFTER REMOVAL IT WAS OBSERVED THAT THE CATHETER TIP WAS DETACHED AND MISSING. FLUOROSCOPY SHOWED THE CATHETER TIP, STILL ON THE WIRE, HAD MIGRATED TO THE FEMORAL ARTERY, AND ALSO SHOWED THE ABSOLUTE STENT HAD FRACTURED AND THE LATERAL WALL OF THE ILIAC ARTERY HAD RUPTURED. AS A RESULT OF BLEEDING THE PATIENT BECAME HYPOTENSIVE AND CARDIAC ARREST OCCURRED THAT WAS TREATED WITH ATROPINE, CARDIOPULMONARY RESUSCITATION, AND BLOOD TRANSFUSIONS. BOTH THE FEMORAL AND ILIAC ARTERIES WERE SURGICALLY REPAIRED AND THE DETACHED DEVICES WERE RETRIEVED. THE PATIENT REMAINS IN THE INTENSIVE CARE UNIT IN FAIR BUT CRITICAL CONDITION. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOX PLUS PTA CATHETER LIT ABBOTT VASCULAR SWITZERLAND NA 523988

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R ABSOLUTE STENT (PART 1010558-80