BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 3124014 · Received May 15, 2013

    Report

    Report Number
    2242352-2013-00463
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 25, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RETURNED TO THE FACTORY FOR EVAL. IT SHOWED NO SIGNS OF CLINICAL USAGE OR EVIDENCE OF BLOOD. THE LOADING DEVICE WAS NOT RETURNED. THE TENSION SPRING ASSEMBLY AND ANCHOR TAB WERE LOCATED INSIDE THE TUBE OF THE DELIVERY DEVICE. THE SEAL WAS EXTENDED OUTSIDE OF THE DELIVERY TUBE; IT REMAINED ANCHORED TO THE TENSION SPRING ASSEMBLY. THE GREEN SLIDE LOCK WAS LOCKED AND WHITE PLUNGER WAS NOT DEPRESSED ON THE DELIVERY DEVICE. BASED UPON THE EVAL RESULTS, 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. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY HARVESTING PROCEDURE, THE HEARTSTRING III SEAL FAILED TO LOAD PROPERLY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214845 HS III PROXIMAL SEAL SYSTEM 3.8MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25064921

    Patients

    Seq Age Sex Outcome Treatment
    1 NA