BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    MDR report key: 2840209 · Received November 14, 2012

    Report

    Report Number
    3005462046-2012-00064
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    LIT
    PMA / PMN Number
    K101735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT INFO IS UNK. ATTEMPTS TO OBTAIN THE PT INFO HAS NOT BEEN SUCCESSFUL. THE ANGIOSCRUPT DEVICE WAS DISCARDED BY THE HOSPITAL, THUS UNABLE TO EVALUATE DEVICE. THE INSTRUCTIONS FOR USE (IFU) FOR THE ANGIOSCULPT SCORING BALLOON CATHETER LISTS RETAINED DEVICE COMPONENTS AS A POSSIBLE ADVERSE EFFECT OF THE PROCEDURE.

    Description of Event or Problem · 1

    WHEN THE DEVICE WAS PULLED OUT OF THE SHEATH, THE NITINOL SCORING ELEMENT HAD DETACHED FROM THE BALLOON. ADDITIONAL INFO PROVIDED BY (B)(6) ON (B)(6) 2012: THE PHYSICIAN FELT RESISTANCE WHILE RETRACTING THE DEVICE FROM THE LESION. USING A LOT OF FORCE, THE PHYSICIAN WAS ABLE TO REMOVE IT FROM THE LESION BUT MORE RESISTANCE WAS FELT WHEN PULLED THROUGH THE 45 CM DESTINATION SHEATH. UPON RETRACTION, IT WAS OBSERVED THAT THE SCORING ELEMENT HAD DETACHED FROM THE BALLOON BUT NO PIECES OF THE DEVICE WAS LEFT BEHIND IN THE PT. NO REWIRING OF THE LESION WAS PERFORMED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) LIT ANGIOSCORE, INC. 2155-3540 F11060014

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO - 45 CM DESTINATION SHEATH