BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBICATH STEERABLE SHEATH

    MDR report key: 2781988 · Received October 5, 2012

    Report

    Report Number
    2183787-2012-00076
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Report Date
    October 3, 2012
    Manufacturer
    GREATBATCH MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K101784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER APPROXIMATELY 30 MINUTES INSIDE BLOOD GLOW AND 25 MINUTES AFTER TSP THERE SEEMED TO BE A CHANGE INSIDE THE MOBICATH. AFTER PULLING THE THERAPY CATHETER BACK INTO THE SHEATH, THE CATHETER SOMEHOW "SUCKED" OUT OF THE SHEATH AND FLIPPED INTO THE LEFT ATRIUM (LA). THE CASE WAS STILL SUCCESSFULLY FINISHED WITH THE MOBICATH AND THERAPY CATHETER (NO PRODUCT CHANGE). THE PHYSICIAN CANNOT APPLY APPROPRIATE PRESSURE AS HE LIKES, BECAUSE THE CATHETER IS TOO MUCH OUTSIDE THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOBICATH STEERABLE SHEATH STEERABLE SHEATH DYB GREATBATCH MEDICAL 1000182-002

    Patients

    Seq Age Sex Outcome Treatment
    1