BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMASHEILD PLAT WOVEN DOUBLE VELOUR GRAFT

    MDR report key: 1213504 · Received October 27, 2008

    Report

    Report Number
    2242352-2008-00010
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 28, 2008
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    MAL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BEING INVESTIGATED. NOTE: NOT ATTAINABLE AT THIS TIME. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. SECTION "F" COMPLETED BY MFR. CODE: THE DEVICE HISTORY RECORDS FOR THE BATCH WERE REVIEWED. CODE: 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

    THE PHYSICIAN CLAIMS THAT DURING AN ASCENDING AORTA REPLACEMENT PROCEDURE IN 2008, THE GRAFT WAS BLEEDING/FLOATING. IT WAS REPORTED, AT THAT TIME, THAT THERE WAS NO INJURY TO THE PATIENT AND THAT THE PATIENT WAS NOT ENDANGERED AN A RESULT OF THE EVENT. ADDITIONAL INFOR RECEIVED 17OCT2008: DURING THE PROCEDURE, BLEEDING WAS OBSERVED ALONG THE LENGTH OF THE GRAFT. THE BLEEDING WAS STOPPED BY WRAPPING WITH HEMOSTATIC AGENTS (TABOTAMP, FIBRIN GLUE), AND CAUSED A 90 MINUTE DELAY IN SURGERY. ALTHOUGH A QUANTATIVE AMOUNT OF BLOOD LOSS WAS NOT REPORTED, IT WAS REPORTED THAT CELL SAVER HAD TO BE USED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS OK, AND APPEARS TO HAVE NOT BEEN ADVERSELY AFFECTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHEILD PLAT WOVEN DOUBLE VELOUR GRAFT SEALED VASCULAR GRAFT MAL MAQUET CARDIOVASCULAR LLC 175128P 11699956

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention