BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK II

    MDR report key: 12562336 · Received October 1, 2021

    Report

    Report Number
    12562336
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    September 9, 2021
    Report Date
    September 14, 2021
    Manufacturer
    B BRAUN INTERVENTIONAL SYSTEMS, INC
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT BROUGHT IN FOR A VALVULOPLASTY. DURING THE PROCEDURE THE VALVULOPLASTY BALLOON RUPTURED. TYSHAK 22MM AORTIC BALLOON RUPTURED WHILE INFLATED ACROSS TAVR AORTIC VALVE. WE BELIEVE THAT THE TAVR STRUT CAUGHT THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1462915 TYSHAK II CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT B BRAUN INTERVENTIONAL SYSTEMS, INC 611937 611937 TT-16835-1 ST-1314

    Patients

    Seq Age Sex Outcome Treatment
    1 30295 DA