BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIVAL PTA BALLOON DILATATION CATHETER

    MDR report key: 2221238 · Received August 15, 2011

    Report

    Report Number
    2020394-2011-00187
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 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
    GM
    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 THIS LOT NUMBER. THE DEVICE WAS RETURNED. VISUAL EXAMINATION OF THE BALLOON FOUND A LONGITUDINAL RUPTURE ON THE BARREL OF THE BALLOON, EXTENDING TOWARDS THE DISTAL CONE. IMAGES WERE NOT PROVIDED, THEREFORE, THE REPORTED VESSEL DISSECTION COULD NOT BE CONFIRMED. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS: 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. POTENTIAL ADVERSE REACTIONS: VESSEL DISSECTION, PERFORATION, RUPTURE, OR SPASM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER DILATATION OF THE BALLOON TO APPROXIMATELY 8 TO 10 ATMS, THE BALLOON RIPPED, RESULTING IN A VESSEL DISSECTION. REPORTEDLY, EXTRAVASATION WAS OBSERVED IN THE FLUOROSCOPIC IMAGE. THE STENT GRAFT THAT WAS INTENDED TO BE IMPLANTED TO TREAT THE LESION AFTER ANGIOPLASTY WAS ALSO USED TO COVER THE DISSECTION. REPORTEDLY, THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIVAL PTA BALLOON DILATATION CATHETER DQY BARD PERIPHERAL VASCULAR, INC. GFUL2621

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention