BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL

    MDR report key: 3193289 · Received June 25, 2013

    Report

    Report Number
    2242352-2013-00617
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR,LLC
    Product Code
    GEI
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED NO SIGNS OF CLINICAL USAGE AND SOME EVIDENCE OF BLOOD. VISUAL INSPECTION DETERMINED THAT THE DELIVERY DEVICE WAS RETURNED OUTSIDE THE LOADING THE DEVICE. THE TENSION SPRING ASSEMBLY, THE ANCHOR TAB AND THE SEAL WERE INSIDE THE BODY OF LOADING DEVICE. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE NOT DEPRESSED ON THE DELIVERY DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III FAILED TO LOAD PROPERLY. THE SEAL REMAINED INSIDE THE LOADER WHEN THE DELIVERY DEVICE WAS REMOVED. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289247 HS III PROXIMAL SEAL CLAMPLESS BEATING HEART GEI MAQUET CARDIOVASCULAR,LLC HS-3045 25067961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA