BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JADE PTA BALLOON DILATATION CATHETER

    MDR report key: 22685805 · Received August 1, 2025

    Report

    Report Number
    22685805
    Event Type
    Malfunction
    Date Received
    August 1, 2025
    Date of Event
    July 14, 2025
    Report Date
    July 21, 2025
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    USED THIS BALLOON WITH A 6FR X 45CM DESTINATION SHEATH. DESPITE DEFLATION OF THE BALLOON UNDER FLUORO AND KEEPING IT UNDER SUCTION WITH INFLATOR, THE BALLOON BROKE IN THE MID POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160553 JADE PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. 597015022 5911122503

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown