BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL

    MDR report key: 3061164 · Received April 10, 2013

    Report

    Report Number
    2242352-2013-00328
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 21, 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

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED NO SIGNS OF CLINICAL USAGE OR EVIDENCE OF BLOOD. THE LOADING DEVICE WAS NOT RETURNED. THE SEAL WAS EXTENDED OUTSIDE OF THE DELIVERY TUBE; IT REMAINED ANCHORED TO THE TENSION SPRING ASSEMBLY. THE SEAL WAS CRACKED ALONG THE FIRST AND FOURTH ROWS FROM THE OUTER EDGE. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE DEPRESSED ON THE DELIVERY DEVICE. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, IT WAS OBSERVED THAT THE HEARTSTRING III SEAL WAS CRACKED DURING THE LOADING PROCESS ALONG THE THIRD AND FOURTH ROW FROM THE OUTSIDE. THE END OF THE SEAL UNRAVELED AS WELL. 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
    149774 HS III PROXIMAL SEAL CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HS-3045 25056479

    Patients

    Seq Age Sex Outcome Treatment
    1 NA