BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX)

    MDR report key: 2971978 · Received February 15, 2013

    Report

    Report Number
    3005462046-2013-00007
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 30, 2013
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    NWX
    PMA / PMN Number
    P050018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANGIOSCULPT DEVICE WAS RETURNED FOR EVAL. VISUAL EXAM CONFIRMED THE BALLOON APPEARED TO HAVE BEEN INFLATED BUT DID NOT IDENTIFY ANY UNUSUAL CHARACTERISTICS. A 0.014" LAB GUIDE WIRE WAS INSERTED INTO THE GUIDE WIRE LUMEN AND ADVANCED WITH NO RESISTANCE. DURING FUNCTIONAL TESTING, A NEGATIVE PREP WAS PERFORMED AND BUBBLES WERE OBSERVED IN THE INDEFLATOR. THE ANGIOSCULPT DEVICE WAS THEN INFLATED TO 8 ATMOSPHERES BUT WAS UNABLE TO HOLD PRESSURE. A SLOW LEAK WAS OBSERVED AT THE STRAIN RELIEF / HUB JUNCTION. EACH DEVICE IS 100% LEAK TESTED PRIOR TO SHIPMENT. PER THE IFU, THE USER IS REQUIRED TO PERFORM A VACUUM PREP PRIOR TO USE OF DEVICE. NO REPORT OF LEAK WAS REPORTED BY THE USER PRIOR TO USE. POTENTIAL MISHANDLING OF THE DEVICE BY THE USER MAY HAVE RESULTED IN THE OBSERVED LEAKAGE AT THE DISTAL END OF THE HUB OUTSIDE THE PT.

    Description of Event or Problem · 1

    THE ANGIOSCULPT DEVICE WAS USED IN THE PT BUT WOULD NOT INFLATE, LEAKING AIR. THE TECH THINKS THERE IS A LEAK OR BAD SEAL BETWEEN THE HUB AND THE BALLOON CAUSING THE DEVICE TO NOT INFLATE PROPERLY. THE CASE WENT ON AS PLANNED AFTER THE REPORTED ANGIOSCULPT DEVICE WAS PULLED AND A NEW ANGIOSCULPT DEVICE WAS USED. PT IS DOING FINE AND HAD NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69483 ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX) NWX ANGIOSCORE, INC. 2034-2510 F12080012

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR