BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELSOFT PLUS

    MDR report key: 8779542 · Received July 11, 2019

    Report

    Report Number
    9612515-2019-00018
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 13, 2019
    Report Date
    July 11, 2019
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    UDI-DI
    05037881115535
    PMA / PMN Number
    K955230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF PRODUCTION RECORDS - A REVIEW OF QC, MANUFACTURING AND PHYSICAL TEST RECORDS WAS PERFORMED AND SHOWED THAT BATCH WAS MANUFACTURED TO DESIGN SPECIFICATION. ALL RELEASED GRAFTS FROM BATCH ALSO MET ACCEPTANCE CRITERIA FOR ALL PHYSICAL TESTS ON BASE MATERIAL AND IN PROCESS TESTING. HISTORICAL DATA REVIEW - A REVIEW OF SIMILAR EVENTS WAS PERFORMED FOR ALL GELSOFT BRANDED DEVICES WHERE LEAKAGE HAS BEEN REPORTED BETWEEN JAN 14 - JUN 19 INCLUSIVE. THE INCIDENT RATE FOR LEAKAGE OF GELSOFT BRANDED DEVICES WAS CONFIRMED AS 0.008% (RATE=COMPLAINTS V SALES). A SIMILAR REVIEW WAS PERFORMED FOR ALL POLYESTER VASCUTEK BRANDED DEVICES WHICH PROVIDED A RATE OF (B)(4). NO NEGATIVE TREND WAS IDENTIFIED DURING THE REVIEW. DEVICE NOT ACCESSIBLE FOR TESTING - ACTUAL DEVICE REMAINS IMPLANTED, THEREFORE NO TESTING COULD BE PERFORMED. NO DEVICE PROBLEM FOUND - REVIEW OF DEVICE BATCH HISTORY RECORDS COULD FIND NO ISSUE WITH BATCH THAT WOULD LEAD TO ISSUE REPORTED DURING PROCEDURE. CAUSE NOT ESTABLISHED - THE REVIEW OF THE RETAINED MANUFACTURING RECORDS AND HISTORICAL COMPLAINTS DATA IDENTIFIED NO ISSUES WITH THE MANUFACTURE OF THE DEVICE OR ANY NEGATIVE TRENDS. AS THE DEVICE WAS UNABLE TO BE RETURNED TO VASCUTEK LTD. FOR ANALYSIS AND NO OTHER DEVICES FROM THIS BATCH WERE AVAILABLE FOR TESTING, NO ROOT CAUSE WAS DETERMINED FOR THE REPORTED ISSUE. VASCUTEK LTD. NOW CONSIDERS THIS COMPLAINT CLOSED HOWEVER, THE ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ON-GOING COMPLAINTS TRENDING AND REPORTING PROCESS AND IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME.

    Description of Event or Problem · 1

    AFTER THE GRAFT WAS ANASTOMOSED (PROXIMAL END) TWO (2) HOLES WERE IDENTIFIED (ONE IN THE BODY AND ONE IN THE RIGHT LEG). THE SURGEONS DECIDED TO KEEP THE GRAFT IN PLACE AND SUTURED THE HOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573981 GELSOFT PLUS GELSOFT PLUS BIFURCATE DSY VASCUTEK LTD 17711917 05037881115535

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention