BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TYCHAK II

    MDR report key: 2302229 · Received September 26, 2011

    Report

    Report Number
    2302229
    Event Type
    Malfunction
    Date Received
    September 26, 2011
    Date of Event
    September 16, 2011
    Report Date
    September 19, 2011
    Manufacturer
    B BRAUN INTERVENTIONAL SYSTEM INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BALLOON WAS BEING USED TO PLACE A STENT. AS THE BALLOON WAS BEING INFLATED, BUT BEFORE STENT WAS FULLY EXPANDED OR BALLOON INFLATED, THE TIP OF THE BALLOON BROKE OFF IN A SEPARATE PIECE. THE TIP WAS INTENTIONALLY RETAINED. THE PATIENT WAS DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TYCHAK II CATHETER, PERCUTANEOUS, BALLOON DQY B BRAUN INTERVENTIONAL SYSTEM INC. PDC545 TT-7131

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR