BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELSOFT PLUS

    MDR report key: 10578693 · Received September 24, 2020

    Report

    Report Number
    9612515-2020-00009
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    August 21, 2020
    Report Date
    September 24, 2020
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    UDI-DI
    05037881115375
    PMA / PMN Number
    K162803
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE: (B)(4). TYPE OF INVESTIGATION: TREND ANALYSIS - REVIEW OF SIMILAR COMPLAINTS FOR ALL GELSOFT PLUS / GELSOFT DEVICES AND LEAKAGE GAVE AN OCCURRENCE RATE OF (B)(4). TYPE OF INVESTIGATION: COMMUNICATION/INTERVIEWS - INFORMATION RECEIVED FROM SITE INDICATED THAT THE DEVICE WAS NOT PRE-SOAKED PRIOR TO PROCEDURE CONTRARY TO IFU WARNINGS AND PRECAUTIONS WHICH STATE "THE PROSTHESIS MUST BE IMMERSED IN A STERILE SALINE SOLUTION FOR 5 MINUTES. FAILURE TO RINSE FOR 5 MINUTES COULD LEAD TO THE GRAFT BEING MORE SUSCEPTIBLE TO LEAKAGE WHEN IMPLANTED" TYPE OF INVESTIGATION: ANALYSIS OF PRODUCTION RECORDS - REVIEW OF QC AND MANUFACTURING RECORDS WITH ATTENTION TO ALL IN PROCESS AND BASE MATERIAL POROSITY TESTS SHOWED BATCH WAS MANUFACTURED TO DESIGN SPECIFICATION AND ALL POROSITY TESTING ON GELLED PRODUCT AND BASE MATERIAL MET ACCEPTANCE CRITERIA. TYPE OF INVESTIGATION - 4114 - DEVICE NOT RETURNED - DEVICE REMAINS IMPLANTED AND WAS NOT RETURNED FOR FURTHER INVESTIGATION. INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND - NO ISSUE WAS FOUND WITH MANUFACTURE OF THE BATCH ON REVIEW OF PRODUCTION RECORDS INVESTIGATION CONCLUSION: CAUSED TRACED TO USER - INFORMATION RECEIVED FROM SITE INDICATED THAT THE DEVICE WAS NOT PRE-SOAKED PRIOR TO USE AS RECOMMENDED IN IFU TO IMPROVE DEVICE HANDLING. THIS MAY HAVE BEEN A CONTRIBUTORY CAUSE OF THE LEAKAGE SEEN. INVESTIGATION CONCLUSIONS: FAILURE TO FOLLOW INSTRUCTIONS - USER DID NOT FOLLOW INSTRUCTIONS IN IFU REGARDING PRE-SOAK OF DEVICE. 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 REPORTED FROM MAASTRICHT UMC+, NETHERLANDS AS FOLLOWS: "NO RELEVANT MEDICAL HISTORY. PATIENT CAME WITH SYMPTOMATIC AAA. NO ANTIPLATELET. 5000U HEPARIN CLAMPING AORTA, PROXIMAL ANASTOMOSIS. CLAMPING DIRECT UNDER PROXIMAL ANASTOMOSIS, MAKING DISTAL ANASTOMOSIS. AFTER RELEASING THE CLAMP, 3 SMALL HOLES IN MID SEGMENT OF GRAFT. 1 HOLE IS SUTURED, OTHER 2 HOLES CLOSED BY MANUAL COMPRESSION. THE EVENT HAD NO CONSEQUENCES FOR POST-OPERATIVE TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045468 GELSOFT PLUS GELSFOT PLUS STRAIGHT DSY VASCUTEK LTD. GELSOFT PLUS STRAIGHT 17601137 05037881115375

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention