BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 1162227 · Received September 16, 2008

    Report

    Report Number
    9710478-2008-00123
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    ABBOTT VASCULAR SWITZERLAND
    Product Code
    LIT
    PMA / PMN Number
    K062843
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. THE FIRST FOX PLUS PTA CATHETER (LOT 462505) IS FILED UNDER MFR # 9710478-2008-00122. THE THIRD FOX PLUS PTA CATHETER (LOT 466632) IS BEING FILED ON A SEPARATE MEDWATCH REPORT.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: BALLOON RUPTURE. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A STENTING PROCEDURE IN THE SUPERFICIAL FEMORAL ARTERY, THE FOX PLUS 4.0X20 BALLOON RUPTURED AT 12 ATMOSPHERES (ATM), DURING THE SECOND INFLATION. A FOX PLUS 4.0X40 WAS INFLATED NEXT; HOWEVER, THIS BALLOON RUPTURED AT 12 ATM DURING THE FIRST INFLATION. A FOX PLUS 5.0X40 WAS THEN INFLATED, BUT THIS BALLOON ALSO RUPTURED AT 12 ATM DURING THE FIRST INFLATION. ALL BALLOONS AND DELIVERY CATHETERS WERE COMPLETELY REMOVED FROM THE BODY WITHOUT DIFFICULTY AND LESION DILATATION WAS COMPLETED USING A NON-ABBOTT DEVICE. THERE WAS NO ADVERSE PATIENT EFFECT. 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 536364

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK FOX PLUS PTA CATHETER (LOT 466632)| FOX PLUS PTA CATHETER (LOT 462505)