BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL SYSTEM, 3.8 MM

    MDR report key: 1791907 · Received August 4, 2010

    Report

    Report Number
    2242352-2010-02361
    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

    INVESTIGATION SUMMARY: THE DEVICE WAS RETURNED TO MAQUET CARDIAC SURGERY ON JULY 16, 2010, FOR INVESTIGATION. A VISUAL INSPECTION REVEALED THAT THE CUTTER HAD BEEN ACTUATED. THE CASING OF THE CUTTER APPEARED TO HAVE SPLIT APART DURING ACTUATION. THE DEVICE WAS BLOODY. BASED UPON THIS VISUAL OBSERVATION, THE REPORTED COMPLAINT "THE HOUSING CAME APART" WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE PRODUCT. THERE WAS NO NONCONFORMANCE WHICH COULD BE ATTRIBUTED TO THIS FAILURE MODE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADD¿L INFO IS OBTAINED. (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 WAS RETURNED.

    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 25010038

    Patients

    Seq Age Sex Outcome Treatment
    1 NA