BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELSOFT PLUS BIFURCATE

    MDR report key: 8526321 · Received April 18, 2019

    Report

    Report Number
    9612515-2019-00006
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Date of Event
    March 20, 2019
    Report Date
    April 17, 2019
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    UDI-DI
    05037881115528
    PMA / PMN Number
    K955230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURERS NARRATIVE: (B)(4). 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 - MAR 19 INCLUSIVE. THE INCIDENT RATE FOR GENERAL LEAKAGE WAS CONFIRMED AS (B)(4) RATE=COMPLAINTS V SALES). NO NEGATIVE TREND WAS IDENTIFIED DURING THE REVIEW. 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

    VASCUTEK LTD RECEIVED A NOTIFICATION FROM OUR (B)(4) DISTRIBUTOR, WHO REPORTED THAT DURING THE IMPLANT OF A GELSOFT PLUS BIFURCATE VASCULAR GRAFT, LEAKAGE WAS REPORTED FROM THE PROXIMAL END OF THE LEFT LIMB OF THE DEVICE. THE LEAKAGE WAS ARRESTED USING LOCALISED MANUAL PRESSURE AND THE APPLICATION OF TACOSEAL TO THE AFFECTED SITE. THE PROCEDURE WAS ELECTIVE AND WAS DEEMED AS SUCCESSFUL WITH NO ADDITIONAL SURGICAL TIME REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319683 GELSOFT PLUS BIFURCATE GELSOFT PLUS BIFURCATE DSY VASCUTEK LTD GELSOFT PLUS BIFURCATE 17107257 05037881115528

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention