BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JADE 14 OTW PTA BALLOON DILATATION CATHETER

    MDR report key: 20104584 · Received August 30, 2024

    Report

    Report Number
    3003775186-2024-00282
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 30, 2024
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD
    Product Code
    LIT
    PMA / PMN Number
    K201794
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A JADE BALLOON RUPTURED IN-VIVO AFTER TREATMENT OF A 80% STENOSED, SEVERELY CALCIFIED, 6MM MID SUPERFICIAL FEMORAL ARTERY. A PIECE OF THE BALLOON WAS LEFT IN THE PATIENT. A SNARE WAS USED TO RETRIEVE THE RUPTURED COMPONENT. THE PATIENT WAS IN STABLE CONDITION. BACKGROUND: 1.RUPTURED COMPONENT RETRIEVED WITH A SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097517 JADE 14 OTW PTA BALLOON DILATATION CATHETER Catheter, angioplasty, peripheral, transluminal LIT ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD 5858072310

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention