BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HS III PROXIMAL SEAL SYSTEM 3.8MM

    MDR report key: 2093425 · Received April 12, 2011

    Report

    Report Number
    2242352-2011-00254
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DXC
    PMA / PMN Number
    K080169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: VISUAL INSPECTION REVEALED THAT THE DELIVERY TUBE WAS RETURNED WITHOUT THE LOADING DEVICE. THE TENSION SPRING ASSEMBLY AND THE SEAL WERE REC'D INSIDE THE DELIVERY TUBE, BUT NOT PROPERLY LOADED. THE SEAL WAS CRACKED ALONG THE SECOND RIM FROM THE EDGE. IT APPEARED THAT THE SEAL HAD BEEN PLACED INTO THE DELIVERY TUBE MANUALLY. THE GREEN SLIDE LOCK AND THE WHITE PLUNGER WERE PARTIALLY DEPRESSED ON THE DELIVERY DEVICE. THERE WAS NO EVIDENCE OF BLOOD ON THE DEVICE. BASE UPON THE REC'D CONDITION OF THE DEVICE, THE REPORTED COMPLAINT "SEAL HAD LOADING ISSUES" COULD NOT BE CONFIRMED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE WHICH COULD HAVE CONTRIBUTED TO THIS FAILURE MODE. (B)(4).

    Description of Event or Problem · 1

    THE HOSP REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, TWO HEARTSTRING III SEALS HAD LOADING ISSUES. A NEW UNIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HS III PROXIMAL SEAL SYSTEM 3.8MM PROXIMAL SEAL DXC MAQUET CARDIOVASCULAR, LLC HSK-3038 25020747

    Patients

    Seq Age Sex Outcome Treatment
    1 NA