BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYSHAK MINI

    MDR report key: 6904305 · Received September 29, 2017

    Report

    Report Number
    6904305
    Event Type
    Malfunction
    Date Received
    September 29, 2017
    Date of Event
    July 10, 2017
    Report Date
    August 25, 2017
    Manufacturer
    B BRAUN INTERVENTIONAL SYSTEMS, INC
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE PREPPING THE BALLOON, THE BALLOON WOULD NOT DEFLATE COMPLETELY. A NEW BALLOON WAS OBTAINED AND PROCEDURE WAS COMPLETED. ORIGINAL DEVICE WAS NOT USED ON PATIENT. REPORTEDLY, THERE WAS NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684527 TYSHAK MINI CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT B BRAUN INTERVENTIONAL SYSTEMS, INC 8MM X 2MM

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR