BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GELWEAVE

    MDR report key: 10910331 · Received November 26, 2020

    Report

    Report Number
    9612515-2020-00017
    Event Type
    Malfunction
    Date Received
    November 26, 2020
    Date of Event
    October 24, 2020
    Report Date
    November 26, 2020
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    UDI-DI
    05037881105130
    PMA / PMN Number
    K952293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE. NO PATIENT INFORMATION PROVIDED. DEVICE WAS USED AS CONDUIT FOR ECMO BYPASS, THEREFORE, WAS NEITHER IMPLANTED, OR EXPLANTED. (B)(4); (B)(4). (B)(4). (B)(4). TYPE OF INVESTIGATION: HISTORICAL DATA ANALYSIS: A REVIEW OF SIMILAR EVENTS RELATED TO GEL WEAVE DEVICES WAS PERFORMED AND GAVE AN OCCURRENCE RATE OF (B)(4). THERE WAS NO INDICATION OF AN INCREASING TREND AND NO FURTHER COMPLAINTS FROM ANY OF THE REMAINING GRAFTS FROM BATCH HAVE BEEN RECEIVED AT THIS TIME. COMMUNICATION/INTERVIEWS: ADDITIONAL INFORMATION WAS REQUESTED FROM SITE ON PROCEDURE, AND IF DEVICE WAS PRE-SOAKED PRIOR TO PROCEDURE AS PER WARNINGS AND PRECAUTIONS IN IFU. SITE INFORMED VASCUTEK ON 23-NOV THAT NO FURTHER INFORMATION ON EVENT, OR DEVICE PREPARATION WAS AVAILABLE. ANALYSIS OF PRODUCTION RECORDS: A REVIEW OF QC AND MANUFACTURING RECORD SHOWED BATCH WAS MANUFACTURED TO SPECIFICATION. ALL PHYSICAL TESTING IN RELATION TO GRAFT POROSITY MET ACCEPTANCE CRITERIA. INVESTIGATION FINDINGS: NO DEVICE PROBLEM FOUND; NO ISSUE WAS FOUND WITH THE MANUFACTURE, AND TESTING OF THE COMPLAINT BATCH. CONCLUSION: 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

    REPORTED TO VASCUTEK LTD. AS FOLLOWS: PATIENT WAS BEING PLACED ON ECMO, AND PRODUCT WAS USED TO GAIN ARTERIAL ACCESS FOR BYPASS. ONCE THE PATIENT WAS PLACED ON BYPASS IT WAS NOTED THAT THERE WAS SIGNIFICANT BLOOD LEAKAGE THROUGH THE GRAFT FABRIC. SURGEON INSPECTED THE GRAFT SUTURE LINE TO DETERMINE WHETHER IT WAS LOCATED THERE, BUT DETERMINED THE LEAKAGE WAS OCCURRING THROUGH THE ENTIRE GRAFT MATERIAL. SURGEON HAD TO INSERT A CANNULA INTO THE GRAFT TO MINIMISE THE BLOOD LOSS FROM THE ARTERY. PATIENT LOST APPROXIMATELY 5L OF BLOOD DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376527 GELWEAVE GELWEAVE STRAIGHT DSY VASCUTEK LTD. GELWEAVE STRAIGHT 21358017 05037881105130

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention