BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYTEM 3.8MM

    MDR report key: 3063374 · Received April 11, 2013

    Report

    Report Number
    2242352-2013-00339
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GEI
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE DELIVERY TUBE, AND ON THE SEAL. THERE WAS EVIDENCE OF BLOOD ON THE EXTERIOR OF THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY, ANCHOR, AND SEAL WERE OUTSIDE THE DELIVERY AND LOADING DEVICES. THE SEAL WAS CRACKED ALONG THE THIRD AND FIFTH ROWS OF THE OUTER EDGE. THE GREEN SLIDE LOCK WAS UNLOCKED AND WHITE PLUNGER WAS DEPRESSED ON THE DELIVERY DEVICE. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED; HOWEVER, IT WAS CONFIRMED FOR CRACKED SEAL. 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 THE DELIVERY TUBE, AND ON THE SEAL. THERE WAS EVIDENCE OF BLOOD ON THE EXTERIOR OF THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY, ANCHOR, AND SEAL WERE OUTSIDE THE DELIVERY AND LOADING DEVICES. THE SEAL WAS CRACKED ALONG THE FOURTH ROW OF THE OUTER EDGE. THE GREEN SLIDE LOCK WAS UNLOCKED AND WHITE PLUNGER WAS DEPRESSED ON THE DELIVERY DEVICE. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED; HOWEVER IT WAS CONFIRMED FOR CRACKED SEAL. 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 SEALS FAILED TO DEPLOY PROPERLY. 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
    155754 HS III PROXIMAL SEAL SYTEM 3.8MM CLAMPLESS BEATING HEART GEI MAQUET CARDIOVASCULAR, LLC HSK-3038 25060606

    Patients

    Seq Age Sex Outcome Treatment
    1 NA