BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8MM

    MDR report key: 1915448 · Received November 4, 2010

    Report

    Report Number
    2242352-2010-03248
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    September 22, 2010
    Report Date
    October 6, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL METHOD: THE DEVICE WILL REPORTEDLY NOT BE RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. 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 LOAD PROPERLY. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS. THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC. HSK-3038 25014978

    Patients

    Seq Age Sex Outcome Treatment
    1 NA