BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX)

    MDR report key: 2053368 · Received March 16, 2011

    Report

    Report Number
    3005462046-2011-00012
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    NWX
    PMA / PMN Number
    P050018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DISPOSED BY HOSPITAL AND LOT NUMBER NOT PROVIDED, THUS CANNOT OBTAIN EXPIRATION DATE AND DEVICE MFR DATE. METHOD: PRODUCT DISPOSED BY HOSPITAL, THUS UNABLE TO EVALUATE DEVICE. RESULTS: THE DEVICE WAS USED IN AN IN-STENT RESTENOSIS (ISR) LESION. DEVICE INTERFERENCE WITH STENT STRUTS OR CALCIFIED LESIONS, IN SUCH INSTANCES, IS AN ANTICIPATED OR KNOWN POSSIBILITY.

    Description of Event or Problem · 1

    INITIAL INFO RECEIVED: THE CLINICIAN HAD A PROBLEM WITH THE BALLOON GETTING STUCK. F/U INFO RECEIVED: THE CLINICIAN USED THE BALLOON IN AN IN-STENT RESTENOSIS (ISR) AND THEN TOOK THE BALLOON THROUGH THE STENT STRUTS INTO A SIDE BRANCH TO INFLATE THERE. THE CLINICIAN COULD NOT GET THE BALLOON BACK THROUGH THE STENT AND FINALLY PULLED NEGATIVE PRESSURE TO REMOVE THE BALLOON. THERE WERE NO PT COMPLICATIONS. THE HOSPITAL HAS DECLINED TO PROVIDE THE PROCEDURAL ANGIOGRAM AND CATHETERIZATION LOG OR REPORT FOR THIS CASE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR