BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIVAL PTA BALLOON DILATATION CATHETER

    MDR report key: 1993433 · Received February 8, 2011

    Report

    Report Number
    2020394-2011-00023
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    PMA / PMN Number
    K052149
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR CORPORATE LOT NUMBER GFUA1400. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER TO DATE. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PTA BALLOON RUPTURED ON THE SECOND INFLATION AT 14 ATM WHILE BEING INFLATED IN A TORTUOUS ANASTOMOSIS OF A NATIVE FISTULA IN THE UPPER ARM. REPORTEDLY, THE BALLOON WAS INFLATED AT AN EXTREME ANGLE WHEN THE BALLOON RUPTURED. ATTEMPTS WERE MADE TO REMOVE THE DEVICE THROUGH THE SHEATH WITH NO SUCCESS. THE CATHETER WAS REMOVED TOGETHER WITH THE SHEATH AS A SINGLE UNIT, BUT THE BALLOON MATERIAL SEPARATED FROM THE CATHETER AND REMAINED IN THE PT. THE BALLOON MATERIAL WAS SURGICALLY REMOVED AND A DIALYSIS GRAFT WAS THEN IMPLANTED. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIVAL PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFUA1400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention