BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELSOFT PLUS

    MDR report key: 8141128 · Received December 7, 2018

    Report

    Report Number
    9612515-2018-00024
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Report Date
    December 7, 2018
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    UDI-DI
    05037881115528
    PMA / PMN Number
    K955230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    3221 - NO FINDING AVAILABLE. CONCLUSION: 4315 - CAUSE NOT ESTABLISHED. ALTHOUGH THE CUSTOMER RETURNED THE GRAFT FOR FURTHER INVESTIGATION, VASCUTEK LTD COULD NOT IDENTIFY THE ROOT CAUSE OF THE EVENT. AS PER THE EVENT INTAKE FORM, THE GRAFT WAS INITIALLY IMPLANTED AND THEN EXPLANTED WHEN A LEAK AT THE BIFURCATION WAS IDENTIFIED. THE STORAGE CONDITIONS BETWEEN EXPLANT AND RETURN (THREE MONTH LATER) ARE UNKNOWN. UPON RECEIPT OF THE GRAFT, IT WAS EXPECTED THAT THE GRAFT HAD BEEN SENT BACK UNMODIFIED AND BLOOD STAINED; HOWEVER, IT APPEARED THAT THE GRAFT HAD BEEN CLEANED AFTER IMPLANT WITH AN UNKNOWN SOLUTION BEFORE RETURN. AS A RESULT, ANY FURTHER TESTING WAS DEEMED INCONCLUSIVE. 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 CONSIDER THIS CASE CLOSED.

    Description of Event or Problem · 0

    THIS REPORT IS BEING SUBMITTED AS FINAL NARRATIVE FOR MFR. REPORT # 9612515-2018-00024 TO PROVIDE CLOSURE INFORMATION FOR THE CASE.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: HISTORICAL DATA ANALYSIS - SIMILAR EVENTS REVIEW WAS CARRIED OUT. ANALYSIS OF PRODUCTION RECORDS - RELEVANT DHR AND QC TEST RECORDS REVIEWED. INSUFFICIENT INFORMATION AVAILABLE - ADDITIONAL INFORMATION REQUESTED FROM THE CUSTOMER. AWAITING DEVICE RETURN. RESULTS: RESULTS PENDING COMPLETION OF INVESTIGATION. 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 SIX PASSED POROSITY TESTING WELL BELOW ACCEPTANCE LIMIT OF 77ML/MIN WITH MINIMUM READING OF 0ML/MIN AND HIGHEST READING OF 05ML/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 (B)(4) 2013 - (B)(4) 2018 INCLUSIVE. NO NEGATIVE TREND WAS IDENTIFIED DURING THE REVIEW. ADDITIONAL INFORMATION ON THE EVENT WAS REQUESTED FROM THE CUSTOMER FOR FURTHER EVENT INVESTIGATION. 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 USA, THE EVENT WAS DESCRIBED AS FOLLOWS: GRAFT WAS LEAKING AT THE POINT OF BIFURCATION AFTER BEING IMPLANTED. LEAK OCCURRED DURING CARDIOPULMONARY BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983152 GELSOFT PLUS GELSOFT PLUS BIFURCATE DSY VASCUTEK LTD 17096509 0986 05037881115528

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization