BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYTEM 3.8MM

    MDR report key: 2062234 · Received March 17, 2011

    Report

    Report Number
    2242352-2011-00151
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 17, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE PRODUCT WILL NOT BE RETURNED TO MAQUET FOR INVESTIGATION. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, FOUR HEARTSTRING III SEALS DID NOT LOAD CORRECTLY. THEY WERE REPORTED AS NOT COILING PROPERLY AND WERE STICKING OUT OF THE DEPLOYMENT TUBE WHEN THE DELIVERY DEVICE WAS REMOVED FROM THE LOADER. A FIFTH NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS III PROXIMAL SEAL SYTEM 3.8MM PROXIMAL SEAL GEI MAQUET CARDIOVASCULAR, LLC HSK-3038 25022681

    Patients

    Seq Age Sex Outcome Treatment
    1 NA