BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM

    MDR report key: 1932176 · Received December 14, 2010

    Report

    Report Number
    2242352-2010-03599
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 15, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: VISUAL INSPECTION REVEALED THAT THE DELIVERY TUBE WAS WITHOUT THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY WAS INSIDE THE DEPLOYMENT TUBE AND THE SEAL WAS EXTENDING OUT OF THE TUBE. THE SEAL WAS INTACT. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE DEPRESSED ON THE DELIVERY DEVICE. THE DEVICE WAS VERY BLOODY. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "SEAL MISFIRED" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD BE ATTRIBUTED TO THIS FAILURE MODE. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE HEARTSTRING III PROXIMAL SEAL LOADED CORRECTLY AND MISFIRED. A NEW KIT WAS USED 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 25017185

    Patients

    Seq Age Sex Outcome Treatment
    1 NA