BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 3876136 · Received May 20, 2014

    Report

    Report Number
    2242352-2014-00583
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION. IT SHOWED NO SIGNS OF CLINICAL USAGE AND SLIGHT EVIDENCE OF BLOOD. THE DELIVERY SERVICE WAS RETURNED OUTSIDE THE LOADING DEVICE. THE SEAL, TENSION SPRING ASSEMBLY AND THE ANCHOR TAB WERE INSIDE THE LOADING DEVICE, NOT IN THE DELIVERY DEVICE. THE SEAL WAS VISIBLE UNDER THE WINDOW OF THE LOADING DEVICE. THE BLUE SLIDE LOCK AND THE WHITE PLUNGER WERE NOT DEPRESSED ON THE DELIVERY DEVICE. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, THE REPORTED COMPLAINT WAS CONFIRMED FOR FAILURE TO LOAD. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. INTERNAL CORRECTIVE ACTION (WY-2013-35) ISSUED FOR THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING 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
    298511 HS III PROXIMAL SEAL SYSTEM 3.8MM ENDOSCOPIC VESSEL HARVESTING DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25094393

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR