BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPPER EXCHANGE DEVICE

    MDR report key: 15657365 · Received October 24, 2022

    Report

    Report Number
    15657365
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    February 22, 2022
    Report Date
    February 24, 2022
    Manufacturer
    CREGANNA UNLIMITED COMPANY
    Product Code
    DQY
    UDI-DI
    05391526210154
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INFLATED TO 16ATM ON DEVICE WHILE IN A 6FR GUIDE CATHETER. TRAPPER WOULD NOT HOLD WIRE IN PLACE WHILE ATTEMPTING TO REMOVE MICRO CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2495341 TRAPPER EXCHANGE DEVICE CATHETER, PERCUTANEOUS DQY CREGANNA UNLIMITED COMPANY H74939330130 3571029505 05391526210154

    Patients

    Seq Age Sex Outcome Treatment
    1 18980 DA Male