BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM

    MDR report key: 1982745 · Received January 6, 2011

    Report

    Report Number
    2242352-2010-03887
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 8, 2010
    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

    INVESTIGATION SUMMARY: VISUAL INSPECTION REVEALED THAT THE DELIVERY TUBE WAS RETURNED SEPARATE FROM THE LOADING DEVICE. THE LOADING DEVICE TOP CLEAR COVER HAD BEEN REMOVED TO REMOVE THE SEAL. THE SEAL AND THE TENSION SPRING ASSEMBLY WERE NOT RETURNED. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE NOT DEPRESSED ON THE DELIVERY DEVICE. THERE WAS NO EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "SEAL REMAINED IN THE LOADING DEVICE" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE SEAL WAS LOADED INTO THE DELIVERY TUBE, AND IT REMAINED IN THE LOADING DEVICE. THE LOADING DEVICE WAS DISASSEMBLED FOR REMOVAL OF THE SEAL, AND THE SURGEON USED THE REPORTED UNIT 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 HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25021394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA