BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING PROXIMAL SEAL, 4.5 MM

    MDR report key: 1883164 · Received October 19, 2010

    Report

    Report Number
    2648729-2010-02761
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    July 29, 2010
    Report Date
    August 16, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K022880
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING PROXIMAL SEAL CRACKED. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING PROXIMAL SEAL, 4.5 MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HS-1045 9082471

    Patients

    Seq Age Sex Outcome Treatment
    1 NA