BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    MDR report key: 3022898 · Received March 20, 2013

    Report

    Report Number
    3005462046-2013-00011
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    LIT
    PMA / PMN Number
    K112182
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT INFO IS UNK. THE HOSPITAL DECLINED TO PROVIDE THE PT INFO. THE ANGIOSCULPT DEVICE WAS RETURNED FOR LAB ANALYSIS. VISUAL EXAMINATION CONFIRMED THE INNER MEMBER DETACHED BETWEEN THE BALLOON TIP SEAL BOND AND THE DISTAL BOND. NO PORTION OF THE ANGIOSCULPT DEVICE SEPARATED FROM THE CATHETER. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) FOR ANGIOSCULPT PTA SCORING BALLOON CATHETER OTW, RETAINED DEVICE COMPONENTS IS LISTED AS A POSSIBLE ADVERSE EFFECT OF THE PROCEDURE.

    Description of Event or Problem · 1

    WHEN REMOVING THE ANGIOSCULPT DEVICE, THE PHYSICIAN NOTED THAT IT APPEARED TO BE TIGHT TO RETRACT. THE ANGIOSCULPT DEVICE WAS REMOVED FROM PT W/O INCIDENT. UPON INSPECTION OF THE DEVICE WHILE ON THE TABLE, THE TECH NOTED THAT THE PROXIMAL SHEATH THAT CONTAINS THE NITINOL SCORING ELEMENT WAS DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116438 ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW) LIT ANGIOSCORE, INC. 2237-60100 F11090035

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK