BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 2192979 · Received July 21, 2011

    Report

    Report Number
    2242352-2011-00983
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 28, 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
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE DELIVERY DEVICE WAS RETURNED SEPARATE FROM THE LOADING DEVICE. THE SEAL AND THE TENSION SPRING ASSEMBLY WERE INSIDE THE BODY OF THE LOADING DEVICE. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE PARTIALLY DEPRESSED ON THE DELIVERY DEVICE. THERE WAS SLIGHT EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "SEAL FAILED TO LOAD" WAS CONFIRMED. 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, THE HEARTSTRING III SEAL FAILED TO LOAD, WHEN THEY WENT TO DEPLOY FROM THE HOLDER, IT GOT STUCK IN THE LOADER INSTEAD OF WHERE IT WAS SUPPOSED TO BE. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT 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 GEI MAQUET CARDIOVASCULAR, LLC HSK-3038 25031748

    Patients

    Seq Age Sex Outcome Treatment
    1 NA