BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM

    MDR report key: 2020634 · Received February 10, 2011

    Report

    Report Number
    2242352-2011-00038
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Report Date
    January 12, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: VISUAL INSPECTION REVEALED THAT THE DELIVERY TUBE WAS RETURNED SEPARATE FROM THE LOADING DEVICE. THE SEAL AND THE TENSION SPRING ASSEMBLY WERE INSIDE THE BODY OF THE LOADING DEVICE. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE NOT DEPRESSED ON THE DELIVERY DEVICE. THERE WAS EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THESE FINDINGS, THE REPORTED FAILURE "SEAL DID NOT LOAD PROPERLY" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNK. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III SEAL DID NOT LOAD PROPERLY. THIS PRODUCT WAS RETURNED WITH OTHER PRODUCTS. AFTER F/U WITH THE REPORTER, IT IS UNK HOW THE PROCEDURE WAS COMPLETED AND IF THERE WERE ANY PT EFFECTS. THE LOT NUMBER, EVENT DATE, AND THE SURGEON ARE ALSO UNK.

    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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA