BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL

    MDR report key: 1881135 · Received October 1, 2010

    Report

    Report Number
    2242352-2010-03008
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 2, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON (B)(6), 2010, FOR INVESTIGATION. VISUAL INSPECTION REVEALED THAT THE DELIVERY DEVICE WAS RETURNED SEPARATE FROM THE LOADING DEVICE. THE SEAL AND TENSION SPRING ASSEMBLY WERE NOT RETURNED. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE DEPRESSED ON THE DELIVERY DEVICE. THE DEVICE WAS BLOODY. GIVEN THAT THE SEAL WAS NOT RETURNED, A CONCLUSION COULD NOT BE MADE ON WHETHER THE SEAL HAD DEPLOYED IMPROPERLY. BASED UPON THESE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT, "SEAL DID NOT DEPLOY PROPERLY" COULD NOT BE 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 A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III PROXIMAL SEAL LOADED BUT DID NOT DEPLOY PROPERLY. THE SEAL IS STILL STUCK IN THE DEPLOYMENT DEVICE. A REPLACEMENT UNIT 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 PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HS-3045 25009814

    Patients

    Seq Age Sex Outcome Treatment
    1 NA