BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTRING III PROXIMAL SEAL 4.3 MM

    MDR report key: 1915445 · Received November 4, 2010

    Report

    Report Number
    2242352-2010-03250
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 8, 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

    INVESTIGATION SUMMARY: THE LOADING DEVICE WAS RETURNED ALONG WITH THE SEAL AND TENSION SPRING ASSEMBLY. THE DELIVERY DEVICE WAS NOT RETURNED. A VISUAL ANALYSIS REVEALED THAT THE SEAL AND THE TENSION SPRING ASSEMBLY WERE STUCK INSIDE THE BODY OF THE LOADER. THERE WAS NO EVIDENCE OF BLOOD ON THE DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, IT APPEARED THAT THE SEAL DID NOT LOAD PROPERLY AS IT REMAINED IN THE LOADING DEVICE. THE REPORTED COMPLAINT "SEAL DEPLOYED WITHIN THE LOADING DEVICE" WAS CONFIRMED. 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 DEPLOYED WITHIN THE LOADING DEVICE. BECAUSE THEY HAVE A NEW SCRUB AND THIS IS THE THIRD ISSUE REPORTED RECENTLY, IT WAS REPORTED THAT IT MAY BE CAUSED BY THE ERROR OF THE INEXPERIENCED SCRUB. THE HOSPITAL WAS IN-SERVICED TO MAKE SURE THEY ARE TRAINED PROPERLY ON THE PROPER LOADING OF THIS DEVICE. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT EFFECTS. THE PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTRING III PROXIMAL SEAL 4.3 MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC. HSK-3043 25016873

    Patients

    Seq Age Sex Outcome Treatment
    1 NA