BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 1003816 · Received February 26, 2008

    Report

    Report Number
    2242352-2008-00002
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    January 28, 2008
    Report Date
    February 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC WAYNE
    Product Code
    MAL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO RECEIVED ON 8 FEB, 2008: THE AMOUNT OF BLOOD LOST WAS REPORTED TO BE " A LITTLE", EXACT QUANTITY UNK. THE BLEEDING OCCURRED AT THE AREA OF THE GRAFT THAT APPEARED TO THE PHYSICIAN TO BE THINNER THAN THE REST OF THE DEVICE. THE TYPE OF SUTURING NEEDLE USED IS UNK AT THIS TIME. SINCE NO PRODUCT WAS RETURNED, THE COMPLAINT COULD NOT BE CONFIRMED OR DENIED. FOLLOWING INVESTIGATION, OUR CONCLUSION AS TO THE MOST PROBABLE ROOT CAUSE IS UNDETERMINABLE. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. THE DEVICE HISTORY RECORDS WERE REVIEWED. RESULTS: ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH OUR STANDARD PROCEDURES. THE DEVICE HISTORY RECORD FOR THIS BATCH SHOWS THAT THE PRODUCT MET ITS SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION- THERE ARE NO SIMILAR INCIDENTS AGAINST THIS BATCH. THERE IS NO INCREASE IN THE FREQUENCY OR SEVERITY AS INDICATED VIA AN ANTICIPATED OR KNOWN FAILURE MODE BASED UPON RISK DOCUMENTATION AND/OR HISTORICAL TRENDING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PHYSICIAN THAT, DURING AN ABDOMINAL AORTIC ANEURYSM REPAIR PROCEDURE, IT WAS NOTICED THAT A SECTION OF THE GRAFT'S MATERIAL SEEMED SLIGHTLY THINNER THAN THAT OF THE REST OF THE DEVICE. AFTER THE DEVICE WAS IMPLANTED, BLOOD LEAKAGE WAS OBSERVED. THE BLOOD LEAKAGE WAS STOPPED BY SUTURING THE GRAFT. THE AMOUNT OF BLOOD LOST WAS NOT REPORTED AT THIS TIME. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE, AND THE DEVICE REMAINED IMPLANTED. IT WAS REPORTED THAT THERE WAS NO INJURY TO THE PT, AND THAT THE PT IS IN GOOD CONDITION. THE FOLLOWING ADDITIONAL INFO WAS RECEIVED ON 5 FEB, 2008: PRIOR TO USE OF THE DEVICE, THE PHYSICIAN VISUALLY INSPECTED THE GRAFT BY STRETCHING IT. IT WAS THEN OBSERVED THAT THERE WAS A THINNER AREA OF THE DEVICE, SEEMING SLIGHTLY TRANSPARENT, AT THE UPPER SIDE OF THE "Y" BRANCH. ONCE IMPLANTED, BLOOD LEAKAGE WAS OBSERVED FROM THE AREA JUST ABOVE THE SUTURE LINES AND NOT ON THE SUTURE LINE. THE PT HAS REMAINED IN THE HOSPITAL IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT SEALED VASCULAR GRAFT MAL BOSTON SCIENTIFIC WAYNE 085201 11213874

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization