BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELSOFT PLUS

    MDR report key: 8631181 · Received May 22, 2019

    Report

    Report Number
    9612515-2019-00008
    Event Type
    Malfunction
    Date Received
    May 22, 2019
    Date of Event
    April 5, 2019
    Report Date
    May 22, 2019
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    UDI-DI
    05037881115528
    PMA / PMN Number
    P890045/S1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIAL NUMBER PROVIDED. NO DOCTOR OR COMPLAINANT NAME PROVIDED. NO REPORT WAS RECEIVED BY VASCUTEK LTD. DIRECTLY OF THE EVENT. INFORMATION ON EVENT PROVIDED BY(B)(6) IN REQUEST FOR INFORMATION FROM MANUFACTURER. (B)(4). A 5-YEAR REVIEW FROM MAY 14 TO MAY 2019 OF SIMILAR PIN HOLE LEAKAGE EVENTS FOR GELSOFT / GELSOFT PLUS GRAFTS WAS PERFORMED. 16 PREVIOUS EVENTS WERE FOUND WHICH GAVE AN OCCURRENCE RATE OF (B)(4) (COMPLAINTS V SALES). QC, MANUFACTURING AND PHYSICAL TESTING RECORDS WERE RETRIEVED AND REVIEWED. REVIEW SHOWED BATCH WAS MANUFACTURED TO SPECIFICATION AND ALL RELEASED DEVICES MET ACCEPTANCE CRITERIA FOR ALL PHYSICAL TESTS. DEVICE REMAINS IMPLANTED AND WAS NOT AVAILABLE FOR TESTING. ALL OTHER GRAFTS IN BATCH HAVE BEEN SHIPPED TO CUSTOMERS. REVIEW OF BATCH QC, MANUFACTURING AND TEST RECORD DID NOT SHOW ANY ISSUE WITH THE MANUFACTURE OF THIS BATCH. NO FURTHER COMPLAINTS HAVE BEEN RECEIVED FROM OTHER GRAFTS IN THIS BATCH. NO ROOT CAUSE FOR THE LEAKAGE COULD BE ESTABLISHED - A REQUEST FOR INFORMATION ON HOW THE GRAFT WAS HANDLED DURING PROCEDURE WAS MADE HOWEVER NO FURTHER INFORMATION WAS RECEIVED. IT IS THEREFORE UNKNOWN WHAT CLAMPS USED AND WHAT TYPE IFU RECOMMENDS ATRAUMATIC SOFT SHOD CLAMPS TO AVOID DAMAGING THE FIBRES OR WHAT TYPE OF NEEDLE USED DURING DE-AIRING. IFU RECOMMENDS THAT THE SMALLEST POSSIBLE NEEDLE SHOULD BE USED AND 19 POINT IS NORMALLY SUFFICIENT. HYPODERMIC NEEDLES HAVE A CUTTING POINT WHICH MAY RESULT IN BLOOD LEAKAGE AND MAY REQUIRE REPAIR BY SUTURING. IF THE GRAFT WAS PRE-SOAKED PRIOR TO USE AS THIS IMPROVE HANDLING PROPERTIES OF THE GRAFT. AS NO FURTHER INFORMATION WILL BE RECEIVED AND GRAFT REMAINS IMPLANTED VASCUTEK LTD. NOW CONSIDERS THIS COMPLAINT CLOSED. 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

    Description of Event or Problem · 1

    EVENT WAS REPORTED TO VASCUTEK (B)(4) BY VASCUTEK (B)(4) WHO RECEIVED NOTIFICATION OF AN EVENT THAT HAD BEEN SUBMITTED TO (B)(6) AND HAD REQUESTED FURTHER INFORMATION ON EVENT. THE EVENT WAS REPORTED AS FOLLOWS: PATIENT TREATED FOR A AAA ON (B)(6) 2019. LEAKAGE ON RIGHT GRAFT LEG DURING DEBUBBLING FROM 3 SMALL HOLES. LEAKAGE STOPPED WITH NATURAL HEMOSTASIS. PATIENT HOSPITAL STAY ENDED (B)(6). THE ONLY INFORMATION RECEIVED WAS FROM INITIAL REPORT AND INFORMATION REQUEST FROM (B)(6) - NO REPORT OF EVENT WAS RECEIVED DIRECTLY BY VASCUTEK (B)(4) OR VASCUTEK (B)(4) FROM HOSPITAL OR COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425871 GELSOFT PLUS GELSOFT PLUS BIFURCATE DSY VASCUTEK LTD. BIFURCATE 17580409 05037881115528

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other