BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL

    MDR report key: 2904073 · Received January 3, 2013

    Report

    Report Number
    2242352-2012-01379
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 3, 2012
    Report Date
    December 10, 2012
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICES ARE NOT AVAILABLE TO BE RETURNED TO US, TECHNICAL EVALUATIONS CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. 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). DEVICE 2: LOT NUMBER: 25062152, EXPIRATION DATE: 07/31/2013.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, TWO HEARTSTRING III SEALS REMAINED INSIDE OF THE LOADING DEVICES. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE HOSPITAL WILL REPORTEDLY NOT BE RETURNING THE PRODUCTS IN QUESTION. SEE PAGE THREE FOR DEVICE 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2287 HS III PROXIMAL SEAL CLAMPLESS BEATING HEART GEI MAQUET CARDIOVASCULAR, LLC. HS-3045 25053010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA