BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTI-PLAST XT PTA BALLOON DILATATION CATHETER

    MDR report key: 1024285 · Received March 27, 2008

    Report

    Report Number
    2020394-2008-00063
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 6, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    LIT
    PMA / PMN Number
    K941706
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNKNOWN. THE SAMPLE WAS NOT RETURNED FOR EVAL AS IT WAS DISCARDED BY THE USER FACILITY. BASED ON THE INFO RECEIVED, THE RESULTS ARE INCONCLUSIVE AND THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RIGHT FEMORAL ARTERY ANGIOPLASTY, THE BALLOON RUPTURED CIRCUMFERENTIALLY AT 5 ATMOSPHERES. THE DOCTOR HAD A DIFFICULT TIME REMOVING THE BALLOON FROM THE SHEATH. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTI-PLAST XT PTA BALLOON DILATATION CATHETER LIT BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1