BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JADE 14 OTW PTA BALLOON DILATATION CATHETER

    MDR report key: 22813616 · Received August 15, 2025

    Report

    Report Number
    3003775186-2025-00287
    Event Type
    Malfunction
    Date Received
    August 15, 2025
    Date of Event
    July 15, 2025
    Report Date
    August 15, 2025
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD
    Product Code
    LIT
    UDI-DI
    06934955901348
    PMA / PMN Number
    K201794
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE JADE BALLOON WAS USED WITH A NON-ABBOTT SHEATH VIA PEDAL ACCESS TO TREAT A LESION IN LEFT SUPERFICIAL FEMORAL ARTERY (SFA). THE BALLOON WAS INFLATED TO 18 ATMOSPHERES (ATM) FOR 2 MINUTES AND THEN DEFLATED. AN INDEFLATOR REMAINED HOOKED TO BALLOON AT NEGATIVE PRESSURE WHILE THE BALLOON WAS REMOVED FROM THE WIRE. THERE WAS RESISTANCE AND THE BALLOON SHEARED OFF AT MIDDLE POINT OF BALLOON, LEAVING HALF OF THE BALLOON ABOUT 50 MILLIMETERS (MM) IN-VIVO AS IT WAS TAKEN OUT OF THE BODY. NEW BALLOONS ACROSS FRAGMENTED BALLOON WERE PLACED TO SNARE THE FRAGMENT AND A SNARE WAS USED TO ATTEMPT FOR REMOVAL OF THE FRAGMENT. A STENT WAS PLACED TO ADHERE BALLOON AGAINST THE ARTERY WALL. THE PATIENT'S STATUS WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1225179 JADE 14 OTW PTA BALLOON DILATATION CATHETER Catheter, angioplasty, peripheral, transluminal LIT ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD 5827242406 06934955901348

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention