BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL 4.3 MM

    MDR report key: 1823767 · Received August 26, 2010

    Report

    Report Number
    2242352-2010-02590
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 28, 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
    FL, 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. A VISUAL INSPECTION REVEALED THAT THE DELIVERY DEVICE WAS RECEIVED SEPARATE FROM THE LOADING DEVICE. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE NOT DEPRESSED ON THE DELIVERY DEVICE. THE SEAL WAS INSIDE THE LOADING DEVICE UNDER THE WINDOW. THERE WAS NO EVIDENCE OF BLOOD. BASED UPON THE VISUAL OBSERVATIONS, THE REPORTED COMPLAINT "DID NOT DEPLOY" WAS NOT CONFIRMED. A FOLLOW-UP WAS MADE WITH THE REPORTER AND IT WAS DETERMINED THAT THE COMPLAINT WAS REPORTED INCORRECTLY. THE FAILURE MODE "FAILURE TO LOAD" WAS CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III SEAL DID NOT DEPLOY. ANOTHER KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING III PROXIMAL SEAL 4.3 MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HSK-3043 25009969

    Patients

    Seq Age Sex Outcome Treatment
    1 NA