BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 2015747 · Received February 18, 2011

    Report

    Report Number
    2242352-2011-00004
    Event Type
    Other
    Date Received
    February 18, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 19, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    MAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND IS, THEREFORE, NOT AVAILABLE FOR EVAL. SINCE THIS EVENT WAS CAUSED BY IMPROPER HANDLING OF THE DEVICE, IT WAS RECOMMENDED THAT THE OPERATING ROOM STAFF BE RE-TRAINED ON THE HANDLING OF THE DEVICE AND THE IFU. THIS TRAINING TOOK PLACE ON (B)(6) 2011 AND (B)(6) 2011, PER THE ACCOUNT TERRITORY MANAGER. FOLLOWING OUR INVESTIGATION, OUR CONCLUSION TO THE ROOT CAUSE IS USER ERROR. METHOD: THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AS REQUIRED. ALL MFG AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH APPLICABLE QUALITY PROCEDURES. RESULTS: THE PRODUCTION BATCH RECORD FOR THIS PRODUCT SHOWS THAT IT WAS RELEASED IN ACCORDANCE WITH ALL GOVERNING QUALITY ASSURANCE/QUALITY CONTROL PROCEDURES PRIOR TO DISTRIBUTION. THERE ARE NO SIMILAR OR OTHER COMPLAINTS AGAINST THE BATCH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS BEING IMPLANTED FOR AN ABDOMINAL AORTIC ANEURYSM REPAIR, WHEN THE OPERATING ROOM CIRCULATOR OPENED THE DEVICE BOX AND REMOVED THE PACKAGING CONTENTS. THE OUTER PLASTIC PACKING, WITH THE WARNING LABELS ABOUT STERILIZATION, WAS OPENED AND THE INNER CONTENTS THEN DROPPED INTO THE STERILE FIELD. SUBSEQUENTLY, THE OUTER TRAY WAS OPENED, POTENTIALLY CONTAMINATING THE SCRUB NURSE. THE SCRUB NURSE PROCEEDED TO OPEN THE INNER TRAY, REMOVE THE GRAFT AND CONTINUE ASSISTING WITH THE IMPLANT OF THE NOW, POTENTIALLY, CONTAMINATED VASCULAR GRAFT. IT WAS DISCOVERED AT SOME POINT IN THE MIDDLE OF THE PROCEDURE THAT THE OUTER TYVEK TRAY WAS NOT STERILE AND HAD BEEN INAPPROPRIATELY INTRODUCED INTO THE STERILE FIELD AND NOW THE PT. A SENTINEL EVENT WAS FILED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT VASCULAR GRAFT MAL MAQUET CARDIOVASCULAR, LLC 085189 25014587

    Patients

    Seq Age Sex Outcome Treatment
    1 NI