BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELSOFT

    MDR report key: 11471915 · Received March 12, 2021

    Report

    Report Number
    9612515-2021-00009
    Event Type
    Malfunction
    Date Received
    March 12, 2021
    Date of Event
    February 25, 2021
    Report Date
    March 12, 2021
    Manufacturer
    VASCUTEK LTD
    Product Code
    DSY
    UDI-DI
    05037881110011
    PMA / PMN Number
    P890045/S1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE ADVISED THAT THE DEVICE IS NOT AVAILABLE; THEREFORE NO EVALUATION OF THE GRAFT WAS POSSIBLE. (B)(4). REVIEW OF SIMILAR COMPLAINTS OF LEAKAGE FOR ALL GELSOFT BRANDED DEVICES GAVE AN OCCURRENCE RATE OF B4. ADDITIONAL INFORMATION WAS REQUESTED FROM THE CLINICIAN REGARDING THE PROCEDURE. A REVIEW OF THE RETAINED QC AND MANUFACTURING RECORDS FOR THIS BATCH (WITH ATTENTION TO ALL IN PROCESS AND BASE MATERIAL POROSITY TESTING) CONFIRMED THAT THE BATCH WAS MANUFACTURED TO ITS DESIGN SPECIFICATION. THE SITE ADVISED THAT THE DEVICE IS NOT AVAILABLE. NO ISSUE WAS FOUND WITH THE MANUFACTURING OF THE BATCH (BASED ON THE REVIEW OF THE RETAINED PRODUCTION RECORDS). THE ROOT CAUSE OF THE REPORTED DEFECT COULD NOT BE DETERMINED. VASCUTEK LTD. CONSIDERS THIS EVENT AS 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, IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME.

    Description of Event or Problem · 1

    VASCUTEK LTD.S (B)(4) DISTRIBUTION PARTNER ((B)(4)) REPORTED AN INCIDENCE OF BLOOD LEAKAGE OF A GELSOFT BIFURCATE GRAFT. THE GRAFT WAS ORIGINALLY IMPLANTED ON (B)(6) 2019. THE PATIENT UNDERWENT A LAPAROTOMY PROCEDURE ON (B)(6) 2021 FOR THE REMOVAL OF A PSEUDO ANEURYSM; IT WAS NOTED AFTER THE REMOVAL OF THE ANEURYSM BLOOD LEAKAGE WAS OBSERVED FROM THE IN-SITU GELSOFT GRAFT. THE EVENT WAS REPORTED TO VASCUTEK LTD. AS POSSIBLY DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375149 GELSOFT GELSOFT DOUBLE BIFURCATE DSY VASCUTEK LTD GELSOFT DOUBLE BIFURCATE 17705600 05037881110011

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention