BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM PLUS BTT/ROUND BALLOON DISSECTOR

    MDR report key: 4110376 · Received September 23, 2014

    Report

    Report Number
    2647580-2014-00784
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 28, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: BALLOON WAS BROKEN. THERE WAS NO UNANTICIPATED TISSUE LOSS. THE INCISION WAS NOT EXTENDED BY MORE THAN ONE INCH. THERE WAS NO UNANTICIPATED BLOOD LOSS OF 500CC OR MORE. SURGERY TIME WAS NOT DELAYED BY MORE THAN 30 MINUTES. NO DEVICE FRAGMENT FELL INTO THE PATIENT. ADDITIONAL INFORMATION REQUESTED VIA EMAIL: 1. WHAT SURGICAL PROCEDURE WAS BEING PERFORMED? 2. COULD YOU PLEASE DESCRIBE THE INCIDENT IN MORE DETAIL? 3. WHAT PART OF THE BALLOON WAS BROKEN? THERE WAS NOT A INCIDENT OTHER THAT THE BALLOON WOULD INFLATE 4. WHAT IS THE PATIENT'S CURRENT STATUS? NO ADDITIONAL INFORMATION CAN BE PROVIDED BY THE ACCOUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592010 SM PLUS BTT/ROUND BALLOON DISSECTOR SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO INC SMBTTRND P4E0432X

    Patients

    Seq Age Sex Outcome Treatment
    1