BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 2093919 · Received April 19, 2011

    Report

    Report Number
    2242352-2011-00405
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED NO NON-CONFORMITIES WITH THE DEVICE. THE BUTTON AND SAFETY LOCK WERE DEPRESSED. THE CUTTER HAD BEEN ACTUATED AND THE CUTTER AND NEEDLE WERE EXTENDED. THE AORTIC PLUG WAS VISIBLE. THERE WAS SLIGHT EVIDENCE OF BLOOD ON THE DEVICE. THE DISTANCE FROM THE AORTIC STOP TO THE CUTTER EDGE WAS MEASURED. A VALUE OF 10.30MM WAS OBTAINED AND WAS FOUND TO BE WITHIN SPECIFICATIONS. THE CUTTING EDGE OF THE TUBE WAS EXAMINED AND NO NON-CONFORMITIES WERE FOUND. THERE WAS NO EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THESE FINDINGS, THE REPORTED COMPLAINT "NEEDLE SEEMED TO EXTEND LONGER THAN USUAL" COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. 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 III AORTIC CUTTER FELT FRAGILE. THERE WERE TWO PROXIMALS NEEDED FOR THIS CASE. BOTH CUTTERS WERE USED WITH NO ISSUES BUT THE SURGEON FELT THAT THE CUTTERS FELT VERY FRAGILE. HE ALSO REPORTED THAT THE NEEDLE SEEMED TO EXTEND LONGER THAN USUAL. NO NEW KITS WERE NEEDED TO COMPLETE THE PROCEDURE. THERE WAS NO DAMAGE TO THE AORTA. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS III PROXIMAL SEAL SYSTEM 3.8MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25027271

    Patients

    Seq Age Sex Outcome Treatment
    1 NA