BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYTEM 3.8MM

    MDR report key: 2802415 · Received October 18, 2012

    Report

    Report Number
    2242352-2012-01078
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES HAVE BEEN RETURNED TO THE FACTORY AND ARE BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVAL ARE COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR EACH OF THE REPORTED PRODUCT LOT NUMBERS. THERE WERE NO NON-CONFORMANCES RECORDED IN THE LOT HISTORIES. (B)(4). DEVICES 2 AND 3:, LOT# 25057441, EXPIRATION DATE: 04/30/2013.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THREE HEARTSTRING III SEALS FAILED TO DEPLOY PROPERLY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS III PROXIMAL SEAL SYTEM 3.8MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25062498

    Patients

    Seq Age Sex Outcome Treatment
    1 NA