BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL

    MDR report key: 2982931 · Received February 22, 2013

    Report

    Report Number
    2242352-2013-00123
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 29, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: THE DEVICE WAS RETURNED TO THE FACTORY FOR EVAL. IT SHOWED NO SIGNS OF CLINICAL USAGE OR EVIDENCE OF BLOOD. THE LOADING DEVICE WAS NOT RETURNED. THE TENSION SPRING ASSEMBLY, ANCHOR TAB AND SEAL WERE INSIDE OF THE DELIVERY DEVICE TUBE. THE DELIVERY TUBE WAS BENT. WHILE WE CANNOT CONCLUSIVELY DETERMINE WHY THE TUBE WAS BENT, IT APPEARS THAT IT MAY HAVE BEEN MANUALLY MANIPULATED. THE GREEN SLIDE LOCK WAS UNLOCKED AND THE WHITE PLUNGER WAS DEPRESSED ON THE DELIVERY DEVICE. THIS FAILURE IS POTENTIALLY ATTRIBUTED TO USER TECHNIQUE AS THERE WAS NO EVIDENCE OF BLOOD IN THE DELIVERY DEVICE. PER THE IFU, BLOOD WITHIN THE DELIVERY DEVICE IS AN INDICATION OF PROPER INSERTION. IT APPEARS THAT THE SEAL WAS ATTEMPTED TO BE DEPLOYED PREMATURELY. AS STATED IN THE IFU, THE USER SHOULD ENSURE THAT THE LOCK IS LOCKED. IF THE LOCK IS UNLOCKED, CARE SHOULD BE TAKEN TO AVOID ANY ACCIDENTAL DEPRESSING OF THE PLUNGER. BASED UPON THE EVAL RESULTS, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED FOR FAILURE TO DEPLOY; HOWEVER, IT WAS CONFIRMED FOR PREMATURE DEPLOYMENT. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. THE EVAL RESULTS AND A COPY OF THE IFU WERE PROVIDED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III SEAL FAILED TO DEPLOY PROPERLY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77545 HS III PROXIMAL SEAL CLAMPLESS BEATING HEAT DXC MAQUET CARDIOVASCULAR, LLC HS-3045 25067961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA