BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOX PLUS PTA CATHETER

    MDR report key: 1202216 · Received October 16, 2008

    Report

    Report Number
    9710478-2008-00140
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ABBOTT VASCULAR-VASCULAR SOLUTIONS
    Product Code
    LIT
    PMA / PMN Number
    K062843
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVAL. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: BALLOON RUPTURE. TIME OF MALFUNCTION: DURING PROCEDURE. SYMPTOMS/AE: NONE. IT WAS REPORTED THAT DURING A SUPERFICIAL FEMORAL ARTERY ANGIOPLASTY, THE BALLOON RUPTURED ON THE FIRST INFLATION AT NO MORE THAN 12 ATMS. THERE WERE NO ADVERSE PT EFFECTS REPORTED. ALTHOUGH REQUESTED, THERE IS NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOX PLUS PTA CATHETER LIT ABBOTT VASCULAR-VASCULAR SOLUTIONS NA 546298

    Patients

    Seq Age Sex Outcome Treatment
    1