BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JADE 14 OTW PTA BALLOON DILATATION CATHETER

    MDR report key: 20122974 · Received September 3, 2024

    Report

    Report Number
    3003775186-2024-00314
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 15, 2024
    Report Date
    September 3, 2024
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD
    Product Code
    LIT
    UDI-DI
    06934955901386
    PMA / PMN Number
    K201794
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DURING PROCEDURE USING A JADE BALLOON INSIDE A STENT IN SUPERFICIAL FEMORAL ARTERY (SFA), THE BALLOON POPPED DURING RETRIEVAL WHEN THE BALLOON GOT STUCK ON THE STRUT OF THE STENT AND GOT DEFLATED. IT RIPPED THE BALLOON IN HALF. THE DISTAL TIP OF THE BALLOON WAS RETRIEVED USING A SNARE. NO FRAGMENTS WERE LEFT IN THE PATIENT'S BODY. ADDITIONAL INFORMATION: THE BALLOON WAS NOT ABLE TO BE INFLATED. PATIENT IS FINE. A REPLACEMENT BALLOON WAS USED WITH NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899472 JADE 14 OTW PTA BALLOON DILATATION CATHETER Catheter, angioplasty, peripheral, transluminal LIT ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD 5862452311 06934955901386

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention