BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYTEM 3.8MM

    MDR report key: 3193315 · Received June 25, 2013

    Report

    Report Number
    2242352-2013-00626
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 7, 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
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED NO SIGNS OF CLINICAL USAGE OR EVIDENCE OF BLOOD. THE DELIVERY DEVICE WAS RETURNED OUTSIDE THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY, ANCHOR TAB AND SEAL WERE INSIDE THE LOADING DEVICE. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE DEPRESSED ON THE DELIVERY DEVICE. THIS FAILURE IS POTENTIALLY ATTRIBUTED TO USER TECHNIQUE. IT APPEARS THAT THE SEAL HAD BEEN PREMATURELY DEPLOYED IN THE LOADING DEVICE. AS STATED IN THE IFU, THE USE 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 EVALUATION RESULTS, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED; 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 CUSTOMER HAS BEEN ADVISED OF OUR EVALUATION RESULTS, AS WELL AS THE RELEVANT SECTION OF THE IFU. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288092 HS III PROXIMAL SEAL SYTEM 3.8MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR,LLC HSK-3038 25063053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA