BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR GRAFT

    MDR report key: 2160416 · Received June 20, 2011

    Report

    Report Number
    2242352-2011-00774
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    MAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING PRODUCT RETURN. METHOD CODE: THE DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AS REQUIRED. ALL MANUFACTURING AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH APPLICABLE QUALITY PROCEDURES. THIS REVIEW EVIDENCED THAT ALL OF THE DEVICES PRODUCED IN THIS BATCH PASSED PERMEABILITY TESTING PER INTERNAL PROCEDURES. RESULTS CODE: 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.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE GRAFT WAS IMPLANTED DURING A THORACIC ANEURYSM REPAIR PROCEDURE, BLOOD LEAKAGE WAS OBSERVED TO BE LEAKING FROM A 2-3MM HOLE IN THE GRAFT. THE GRAFT WAS REPAIRED BY A SUTURE. THE DEVICE REMAINED IMPLANTED AND WAS NOT ADVERSELY AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR GRAFT VASCULAR GRAFT MAL MAQUET CARDIOVASCULAR, LLC 175130P 25030085

    Patients

    Seq Age Sex Outcome Treatment
    1 NI