BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 3050639 · Received March 14, 2013

    Report

    Report Number
    2242352-2013-00270
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: DEVICE 1: THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE. THERE WAS A SIGNIFICANT AMOUNT OF BLOOD ON THE DELIVERY DEVICE, INSIDE OF THE DELIVERY TUBE, AND ON THE SEAL. THE DELIVERY DEVICE WAS RETURNED OUTSIDE OF THE LOADING DEVICE. THE SEAL WAS EXTENDED OUTSIDE OF THE DELIVERY TUBE; IT REMAINED ANCHORED TO THE TENSION SPRING ASSEMBLY, THE SEAL WAS PARTIALLY UNRAVELED ALONG THE THIRD AND FOURTH ROWS FROM THE CENTER. THE GREEN SLIDE LOCK WAS UNLOCKED AND WHITE PLUNGER WAS DEPRESSED ON THE DELIVERY DEVICE. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED FOR THE PARTIALLY UNRAVELED SEAL AND FOR FAILURE TO DEPLOY PROPERLY. DEVICE 2: THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED SIGNS OF CLINICAL USAGE. THERE WAS A SIGNIFICANT AMOUNT OF BLOOD ON THE DELIVERY DEVICE, INSIDE OF THE DELIVERY TUBE, AND ON THE SEAL. THE DELIVERY DEVICE WAS RETURNED OUTSIDE OF THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY, ANCHOR TAB AND THE SEAL WERE LOCATED INSIDE OF THE DELIVERY DEVICE TUBE. THE SEAL WAS PARTIALLY UNRAVELED ALONG THE FIRST ROW FROM THE OUTER EDGE. THE GREEN SLIDE LOCK WAS UNLOCKED AND THE WHITE PLUNGER WAS DEPRESSED ON THE DELIVERY DEVICE. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT WAS CONFIRMED FOR THE UNRAVELED SEAL AND FOR FAILURE TO DEPLOY PROPERLY. A LOT HISTORY RECORD 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, TWO HEARTSTRING III SEALS FAILED TO DEPLOY PROPERLY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE HOSPITAL INTENDS TO RETURN THE PRODUCTS IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108468 HS III PROXIMAL SEAL SYSTEM 3.8MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25067572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA