BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONQUEST PTA BALLOON DILATATION CATHETER

    MDR report key: 1239064 · Received November 14, 2008

    Report

    Report Number
    2020394-2008-00333
    Event Type
    Other
    Date Received
    November 14, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 21, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K014212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW: THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. BASED ON THE INFORMATION AVAILABLE TO DATE, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IN UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE FIRST INFLATION OF THE BALLOON OF A PTA BALLOON DILATATION CATHETER, INFLATED TO 25 ATM, COULD ALLEGEDLY NOT BE DEFLATED. THE PHYSICIAN ATTEMPTED TO IRRIGATE WITH SALINE AND DEFLATED THE BALLOON FOR 10 MINUTES WITH NO EFFECT. REPORTEDLY, THE PHYSICIAN EVENTUALLY DEFLATED THE BALLOON USING A LOCAL NEEDLE TO PUNCTURE IT TWICE. THE PTA PROCEDURE WAS BEING PERFORMED IN A LEFT FOREARM AV FISTULA VEIN STENOSIS. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONQUEST PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFRF1703

    Patients

    Seq Age Sex Outcome Treatment
    1