BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONQUEST PTA BALLOON DILATATION CATHETER

    MDR report key: 1061765 · Received June 13, 2008

    Report

    Report Number
    2020394-2008-00166
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 30, 2008
    Report Date
    June 2, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K014212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 DISCARDED BY THE USER FACILITY, SO A SAMPLE EVALUATION COULD NOT BE PERFORMED. IT IS UNKNOWN IF PATIENT OR PROCEDURAL FACTORS CONTRIBUTED TO THIS EVENT. BASED ON THE INFORMATION RECEIVED, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNKNOWN. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNING: DO NOT EXCEED THE RBP RECOMMENDED FOR THIS DEVICE. BALLOON RUPTURE MAY OCCUR IF THE RBP RATING IS EXCEEDED. TO PREVENT OVER PRESSURIZATION, USE OF A PRESSURE MONITORING DEVICE IS RECOMMENDED. THE CURRENT IFU (INSTRUCTIONS FOR USE) FOR THIS DEVICE STATES: EQUIPMENT REQUIRED: LUER LOCK SYRINGE/INFLATION DEVICE WITH MANOMETER (10 ML OR LARGER).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SHUNTOGRAMS FOR INTRAVENOUS STENOSIS OF AN AV FISTULA, THE PTA BALLOON WAS INFLATED WITH A SYRINGE, AND ON THE FIRST INFLATION, THE BALLOON RUPTURED CIRCUMFERENTIALLY. THE PATIENT DID NOT HAVE ANY IMPLANTED STENTS. THERE WAS NO REPORTED INJURY TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1