BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELSOFT PLUS

    MDR report key: 8315755 · Received February 7, 2019

    Report

    Report Number
    9612515-2019-00002
    Event Type
    Malfunction
    Date Received
    February 7, 2019
    Date of Event
    January 11, 2019
    Report Date
    March 7, 2019
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    UDI-DI
    05037881115511
    PMA / PMN Number
    K955230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT CODE: 213 - NO DEVICE PROBLEM FOUND - RETURNED DEVICE ANALYSIS DID NOT IDENTIFY ANY ISSUES WITH THE GRAFT STRUCTURE. CONCLUSION CODE: 4315 - CAUSE NOT ESTABLISHED - ROOT CAUSE OF THE EVENT COULD NOT BE ESTABLISHED. ONLY PART OF THE DEVICE WAS RETURNED THE REST OF THE GRAFT IS STILL IMPLANTED. PART OF GRAFT WAS RETURNED FOR FURTHER ANALYSIS TO VASCUTEK LTD. RETURNED PART WAS MEASURED TO 40MM, THAT IS NOT SUBSTANTIAL SIZE TO PERFORM LEAK TEST; HOWEVER, BURST TEST WAS CARRIED OUT TO CHECK THE STRENGTH OF MATERIAL. THE RESULTS WERE WITHIN SPECIFICATION. ACCEPTANCE CRITERIA FOR BODY AND SEAM PARTS OF THE GRAFT ARE MINIMUM OF 213N - BODY AND 214N - SEAM. RESULTS FOR THE RETURNED PART OF THE GRAFT WERE 326N - BODY AND 286N - SEAM. THERE WERE NO ISSUES FOUND WITH GRAFT MATERIAL DURING FURTHER ANALYSIS. VASCUTEK LTD COULD NOT IDENTIFY THE ROOT CAUSE OF THE EVENT REPORTED. FURTHER ACTION IS NOT PLANNED; 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. VASCUTEK LTD CONSIDERS THIS COMPLAINT CLOSED.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED AS FINAL NARRATIVE FOR MFR. REPORT # (B)(4) TO PROVIDE CLOSURE INFORMATION FOR THE CASE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE RETAINED MANUFACTURING AND QUALITY RECORDS (WITH SPECIFIC EMPHASIS OF THE BASE MATERIAL PERMEABILITY AND DEVICE POROSITY TESTING) CONFIRMED THAT THE PRODUCT WAS MANUFACTURED TO THE INTENDED SPECIFICATIONS. THE WHOLE BATCH OF FOUR PASSED POROSITY TESTING WELL BELOW ACCEPTANCE LIMIT OF 67ML/MIN WITH MINIMUM READING OF 04ML/MIN AND HIGHEST READING OF 08ML/MIN. A REVIEW OF SIMILAR EVENTS WAS PERFORMED FOR ALL KNITTED DEVICES THAT HAVE BEEN REPORTED TO HAVE LEAKED. THE INCIDENT RATE FOR REPORTED LEAKAGE EVENTS WAS CONFIRMED AS (B)(4) (COMPLAINTS V SALES). THE REVIEW INCLUDED ALL SIMILAR EVENTS REPORTED TO VASCUTEK BETWEEN JAN 2014 - JAN 2019 INCLUSIVE. NO NEGATIVE TREND WAS IDENTIFIED DURING THE REVIEW. CUSTOMER IS RETURNING PART OF THE GRAFT FOR FURTHER ANALYSIS. INVESTIGATION RESULTS WILL BE COMMUNICATED IN FOLLOW UP / FINAL REPORT.

    Description of Event or Problem · 1

    VASCUTEK LTD. WAS NOTIFIED OF AN EVENT THAT OCCURRED IN (B)(6), THE EVENT WAS DESCRIBED AS FOLLOWS: WHEN PERFORMING AN ANASTOMOSIS, A 1MM PIN HOLE WAS FOUND AROUND 1CM FROM THE GRAFT BIFURCATION. PHYSICIAN STITCHED UP THE PIN HOLE WITH ONE STITCH AND CONFIRMED THAT NO LEAKAGE OCCURRED WHEN BLOOD FLOW WAS RESTORED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111448 GELSOFT PLUS GELSOFT PLUS BIFURCATE DSY VASCUTEK LTD 17347066 1147 05037881115511

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention