BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT

    MDR report key: 86450 · Received April 22, 1997

    Report

    Report Number
    2242352-1997-00037
    Event Type
    Malfunction
    Date Received
    April 22, 1997
    Date of Event
    March 15, 1997
    Report Date
    March 27, 1997
    Manufacturer
    MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
    Product Code
    MAL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURNED, UNUSED PORTION OF THE IMPLANTED GRAFT WAS EVALUATED BY OUR CONSULTING PATHOLOGIST. CODE 86: THE MFG BATCH RECORDS FOR THE DEVICE WERE REVIEWED. CODE 100: THE BATCH RECORDS WERE NOT ATYPICAL - ONE SIMILAR INCIDENT HAS BEEN REPORTED AGAINST THIS BATCH. GROSS DESCRIPTION: RECEIVED IN FORMALIN IS A SEGMENT OF DACRON VASCULAR GRAFT WHICH MEASURES 6.9CM IN LENGTH BY 1.0CM IN DIAMETER. THE DACRON VASCULAR GRAFT IS CRIMPED. NO BLOOD OR TISSUE ELEMENTS ARE IDENTIFIED. REP. SECTIONS ARE EMBEDDED UNDER MD-957 AND MD-958. MICROSCOPIC DESCRIPTION: AN INTACT DACRON VASCULAR GRAFT WITH COATING IS IDENTIFIED. THE COLLAGEN COATING IS INTACT ON THE LUMINAL SURFACE AND PERIADVENTITIAL SURFACE OF THE VASCULAR GRAFT. COLLAGEN COATING IS PRESENT WITHIN THE INTERSTICES OF THE VASCULAR GRAFT. NO BLOOD OR TISSUE COMPONENTS ARE IDENTIFIED. SUMMARY: AN INTACT DACRON VASCULAR GRAFT WITH INTACT COLLAGEN COATING IS IDENTIFIED. NO BLOOD OR TISSUE COMPONENTS ARE IDENTIFIED.

    Description of Event or Problem · 1

    AFTER PERFORMING THE PROXIMAL ANASTOMOSIS AND DECLAMPING THE ARTERY, THE GRAFT LEAKED APPROXIMATELY 150CC OF BLOOD FROM ITS WALLS OVER A PERIOD OF APPROXIMATELY 1 TO 2 MINUTES. THE GRAFT WAS LEFT IN. THE PATIENT'S CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD MICROVEL DOUBLE VELOUR GRAFT Implant SEALED VASCUALR GRAFT MAL MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. 095308 106153

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other