BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 1190721 · Received October 6, 2008

    Report

    Report Number
    9710478-2008-00134
    Event Type
    Malfunction
    Date Received
    October 6, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 16, 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 CUSTOMER REPORTED THE DEVICE WAS DISCARDED. WITHOUT DEVICE INVESTIGATION, A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER WAS PROVIDED. A 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. TIME OF MALFUNCTION: DURING THE PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING AN INTERVENTIONAL PROCEDURE IN THE ILIAC ARTERY, THE FOX PLUS BALLOON RUPTURED AT 10 ATMOSPHERES. THE BALLOON AND DELIVERY CATHETER WERE COMPLETELY REMOVED FROM THE BODY AND DILATATION WAS PERFORMED USING ANOTHER FOX PLUS BALLOON. THERE WAS NO ADVERSE PATIENT EFFECT. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOX PLUS PTA CATHETER LIT ABBOTT VASCULAR SWITZERLAND NA 507352

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK