BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 4.3MM

    MDR report key: 3021008 · Received March 20, 2013

    Report

    Report Number
    2242352-2013-00266
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 SOME EVIDENCE OF BLOOD ON THE DELIVERY DEVICE, INSIDE OF THE DELIVERY TUBE AND ON THE SEAL. THE LOADING DEVICE WAS NOT RETURNED. THE TENSION SPRING ASSEMBLY WAS LOCATED INSIDE OF THE DELIVERY DEVICE TUBE; IT REMAINED ANCHORED TO THE TENSION SPRING ASSEMBLY. THE GREEN SLIDE LOCK WAS UNLOCKED AND THE WHITE PLUNGER WAS DEPRESSED ON THE DELIVERY DEVICE. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED FOR FAILURE TO LOAD; HOWEVER, IT WAS CONFIRMED FOR FAILURE TO DEPLOY. 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 LOADING DEVICE WAS NOT RETURNED. THE TENSION SPRING ASSEMBLY WAS LOCATED INSIDE OF THE DELIVERY DEVICE TUBE; IT REMAINED ANCHORED TO THE TENSION SPRING ASSEMBLY. THE GREEN SLIDE LOCK WAS UNLOCKED AND THE WHITE PLUNGER WAS DEPRESSED ON THE DELIVERY DEVICE. BASED UPON THE EVALUATION RESULTS, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED FOR FAILURE TO LOAD; HOWEVER, IT WAS CONFIRMED FOR FAILURE TO DEPLOY. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, TWO HEARTSTRING III SEAL FAILED TO LOAD PROPERLY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSP DID NOT REPORT ANY PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116947 HS III PROXIMAL SEAL SYSTEM 4.3MM CLAMPLESS BEATING HEART DXC MAQUET CARDIOVASCULAR, LLC HSK-3043 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA