BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL

    MDR report key: 3140110 · Received May 29, 2013

    Report

    Report Number
    2242352-2013-00505
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE. THERE WAS BLOOD INSIDE THE DELIVERY TUBE, ON THE SEAL, AND OUTSIDE OF THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY WAS INSIDE OF THE DELIVERY TUBE. THE SEAL WAS EXTENDED OUTSIDE OF THE DELIVERY TUBE; IT REMAINED ANCHORED TO THE TENSION SPRING ASSEMBLY. THE GREEN SLIDE LOCK WAS UNLOCKED AND WHITE PLUNGER WAS DEPRESSED ON THE DELIVERY DEVICE. BASED ON THE EVALUATION RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED. A LOT HISTORY REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (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 INTO THE AORTOTOMY UPON ACTUATING THE PLUNGER. 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
    236190 HS III PROXIMAL SEAL CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HS-3045 25073268

    Patients

    Seq Age Sex Outcome Treatment
    1 NA