BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELWEAVE

    MDR report key: 3648075 · Received February 14, 2014

    Report

    Report Number
    9612515-2014-00001
    Event Type
    Other
    Date Received
    February 14, 2014
    Date of Event
    January 16, 2014
    Report Date
    February 14, 2014
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    PMA / PMN Number
    K952293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE RETURNED SECTION OF THE GRAFT WAS INSPECTED AND EVALUATED. PHOTOGRAPHS OF THE GRAFT WERE TAKEN TO DOCUMENT ITS CONDITION UPON ARRIVAL. A VISUAL EXAMINATION OF THE GRAFT WAS UNDERTAKEN. CHEMICAL TESTING WAS UNDERTAKEN TO DETERMINE IDENTIFICATION OF EXCESS MATERIAL. RESULTS: INVESTIGATION HAS IDENTIFIED AN AREA OF THE PROCESS OF GELATIN APPLICATION A GRAFT CUTTING WHICH HAS THE POTENTIAL TO ALLOW THE DEFECT TO OCCUR. THERE WAS A FAILURE IN THE INSPECTION PROCESS WHICH ALLOWED THE DEFECT TO ESCAPE. CONCLUSIONS: PROCESS IMPROVEMENTS ARE CURRENTLY BEING EVALUATED. FROM THE (B)(4) GRAFTS THAT WERE MANUFACTURED AND RELEASED, (B)(4) HAVE BEEN SUCCESSFULLY IMPLANTED AND HAVE NOT EXHIBITED THE WEBBING EFFECT AS IDENTIFIED IN THE COMPLAINT GRAFT. THEREFORE THIS DEFECT IS NOT PRESENT IN THE WHOLE BATCH AND IS MOST LIKELY LIMITED TO SINGLE COMPLAINT GRAFT. AN ADD'L QC VERIFICATION CHECK HAS ALSO BEEN INTRODUCED TO THE FINAL INSPECTION STAGE SINCE THE DATE OF MANUFACTURE OF THE COMPLAINT GRAFT AND IS HOPED THAT THIS WILL HELP ELIMINATE FUTURE RECURRENCE OF THIS TYPE OF EVENT.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED TO VASCUTEK AS FOLLOWS: BEFORE IMPLANTING THE GRAFT IN QUESTION, DR. FOUND THE PRESENCE OF A GELATIN-LIKE LUMP INSIDE THE LUMEN OF THE GRAFT. THE SUBSTANCE WAS CUT OFF AND REMOVED BEFORE THE OPERATION. THE OPERATION WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97969 GELWEAVE VASCULAR PROSTHESIS DSY VASCUTEK LTD GELWEAVE 318802 5802

    Patients

    Seq Age Sex Outcome Treatment
    1 Other