BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 2201691 · Received August 4, 2011

    Report

    Report Number
    2242352-2011-01072
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 15, 2011
    Report Date
    July 18, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING INVESTIGATED AND THE RESULTS ARE BEING EVALUATED AND ANALYZED WITH SIMILAR EVENTS. A F/U REPORT WILL BE SUBMITTED ONCE THE DEVICE EVAL IS COMPLETE. ITEMS MARKED "NI" ARE UNK TO US AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III SEAL FAILED TO LOAD. THE REPORTER STATED THAT THE SEAL WOULD NOT COME OUT OF THE LOADER. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS III PROXIMAL SEAL SYSTEM 3.8MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA