BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM

    MDR report key: 1791924 · Received August 4, 2010

    Report

    Report Number
    2242352-2010-02362
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    June 24, 2010
    Report Date
    July 7, 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
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD ¿ THE DEVICE HAS NOT BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE IS RETURNED AND THE INVESTIGATION HAS BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, WHEN THE BUTTON ON THE AORTIC CUTTER OF THE HEARTSTRING III PROXIMAL SEAL SYSTEM WAS PUSHED, IT MADE A NOISE, THE HOUSING CAME APART, AND THE CUTTER CAME OUT FURTHER THAN USUAL. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT IS RETURNING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA