BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELSOFT PLUS

    MDR report key: 8797150 · Received July 17, 2019

    Report

    Report Number
    9612515-2019-00019
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    June 19, 2019
    Report Date
    July 17, 2019
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    UDI-DI
    05037881115528
    PMA / PMN Number
    K955230
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT: NO REPORTED SIGNIFICANT DELAY TO PROCEDURE, PATIENT CONSEQUENCE OR HARM. BLEEDING WAS HALTED WITH APPLICATION OF SUTURE AND PATIENT REPORTED AS STABLE POST OP. (B)(4). HISTORICAL DATA ANALYSIS: A 5-YEAR REVIEW OF PREVIOUS GELSOFT PLUS COMPLAINTS WAS CARRIED OUT AND GAVE AN OCCURRENCE RATE OF 0.010%. ANALYSIS OF PRODUCTION RECORDS: REVIEW OF RETAINED QC, MANUFACTURING AND PHYSICAL TESTING RECORDS PERFORMED: A REVIEW OF RETAINED QC AND MANUFACTURING RECORDS SHOWED THAT THIS BATCH WAS MANUFACTURED TO SPECIFICATION WITH NO ISSUES RAISED. A REVIEW OF THE GRAFT BASE MATERIAL PHYSICAL TESTS SHOWED ALL TESTING MET ACCEPTANCE CRITERIA. BASE MATERIAL POROSITY TESTS AND FINISHED PRODUCT POROSITY TESTS WERE ALL WITHIN SPECIFICATION WITH NO ISSUES HIGHLIGHTED. DEVICE NOT ACCESSIBLE FOR TESTING: DEVICE REMAINS IMPLANTED IN PATIENT AND WILL NOT BE RETURNED FOR TESTING. NO DEVICE PROBLEM FOUND: REVIEW OF PRODUCT BATCH RECORDS SHOWED NO ISSUE WITH THE MANUFACTURE OF THIS BATCH. CAUSE NOT ESTABLISHED - CAUSE OF THE LEAKAGE COULD NOT BE ESTABLISHED FROM REVIEW OF QC AND MANUFACTURING RECORDS: RESPONSE TO QUESTION FROM SITE DID NOT INDICATE ANY DEVIATION FROM IFU RECOMMENDATIONS OR MISHANDLING OF PRODUCT. VASCUTEK LTD. IS SUBMITTING THIS REPORT AS AN INITIAL/FINAL REPORT . NO FURTHER INFORMATION AVAILABLE AND NO INVESTIGATION IS POSSIBLE AS DEVICE REMAINS IMPLANTED. 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

    EVENT WAS REPORTED TO VASCUTEK LTD. AS FOLLOWS: AFTER THE IMPLANT WAS ANASTOMOSED (PROXIMAL), THE SURGEON NOTICED ONE (1) HOLE IN THE GRAFT (AT THE BIFURCATION LEVEL). THE SURGEON DECIDED TO KEEP THE GRAFT IN PLACE AND SUTURE THE HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594396 GELSOFT PLUS GELSOFT PLUS GELATIN IMPREGNATED KNITTED VASCULAR PROSTHESIS DSY VASCUTEK LTD. GELSOFT PLUS BIFURCATE 17602557 05037881115528

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention