BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II

    MDR report key: 15492153 · Received September 27, 2022

    Report

    Report Number
    15492153
    Event Type
    Malfunction
    Date Received
    September 27, 2022
    Date of Event
    September 14, 2022
    Report Date
    September 21, 2022
    Manufacturer
    B BRAUN INTERVENTIONAL SYSTEMS, INC
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE BALLOON RUPTURED AFTER INFLATION IN THE MID (RENAL) IVC. THE RUPTURED BALLOON BROKE IN HALF AND THE INNER SHEATH REMNANT OF THE BALLOON WAS STUCK ON THE WIRE. THE BALLOON WAS RETRIEVED; HOWEVER, A PIECE OF THE BALLOON WAS LEFT BEHIND (DETECTED BY IVUS) AND WAS UNABLE TO BE RETRIEVED. THE PATIENT IS STABLE AND WILL BE ADMITTED OVERNIGHT FOR OBSERVATION. THE MD DOES NOT FEEL THAT THE BALLOON WAS DEFECTIVE. MANUFACTURER RESPONSE FOR BALLOON, TYSHAK II 8 FR. 20 MM X 4.0 CM (PER SITE REPORTER) PRODUCT HANDLED BY SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2304137 TYSHAK II CATHETER, PERCUTANEOUS DQY B BRAUN INTERVENTIONAL SYSTEMS, INC 611932

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown