BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 2901566 · Received January 4, 2013

    Report

    Report Number
    2242352-2012-01385
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 11, 2012
    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

    THE DEVICES HAVE NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICES. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICES ARE RECEIVED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR EACH OF THE REPORTED PRODUCT LOT NUMBERS. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4). DEVICE 3: HS III PROXIMAL SEAL SYSTEM 4.3MM, MODEL #HSK-3043, LOT #25059246, EXPIRATION DATE: 05/31/2013.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THREE HEARTSTRING III SEALS FAILED TO LOAD PROPERLY. A FOURTH REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL INTENDS TO RETURN THE PRODUCTS IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4361 HS III PROXIMAL SEAL SYSTEM 3.8MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25067071

    Patients

    Seq Age Sex Outcome Treatment
    1 NA