BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL 4.3MM

    MDR report key: 1900374 · Received October 26, 2010

    Report

    Report Number
    2242352-2010-03163
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 27, 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
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A VISUAL INSPECTION REVEALED THAT THE DELIVERY DEVICE WAS RETURNED INSIDE THE LOADING DEVICE. THE SEAL WAS INSIDE THE LOADING DEVICE UNDER THE WINDOW. 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, "THE SEAL DID NOT ROLL PROPERLY" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED 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 DID NOT ROLL PROPERLY. THE ROLLING OF THE SEAL WAS UNBALANCED, EVEN THOUGH THEY WERE PRESSING THE BUTTON ACCORDING TO INSTRUCTIONS FOR USE (IFU). A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING III PROXIMAL SEAL 4.3MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HSK-3043 25014079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA