BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELSOFT PLUS

    MDR report key: 2612716 · Received June 7, 2012

    Report

    Report Number
    9612515-2012-00004
    Event Type
    Other
    Date Received
    June 7, 2012
    Date of Event
    May 1, 2012
    Report Date
    June 6, 2012
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    PMA / PMN Number
    K955230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VASCUTEK HAS REVIEWED MFG AND QC RECORDS AND FOUND NO ISSUES. THE RETURNED GRAFTS WERE PHOTOGRAPHED, SUBJECTED TO TEXTILE ANALYSIS AND WATER POROSITY TESTING TO CHECK FOR PHYSICAL DEFECTS. SCANNING ELECTRON MICROGRAPHS (SEMS) WERE TAKEN OF THE RETURNED DEVICE TO CHECK THE GROSS AND FINE STRUCTURES OF THE GRAFT. VASCUTEK COULD NOT PERFORM GELATIN AND GLYCEROL CONTENT AS THE GRAFT HAD BEEN IMMERSED IN SALINE OR SIMILAR LIQUID PRIOR TO BEING RETURNED. THIS WAS APPARENT AS THE GRAFT WAS STIFF WHEN EXAMINED. THIS STIFFNESS IS CAUSED BY REMOVAL OF THE GLYCEROL BY SALINE OR SIMILAR LIQUID. IMMERSION ALSO STARTS TO HYDROLYZE THE GELATIN, MAKING ANY RESULTS INACCURATE. RESULTS: THE GRAFT WAS RETURNED TO VASCUTEK FOR ANALYSIS. THE RESULTANT REPORT WAS SENT TO THE DOCTOR WITH A LETTER. THE GRAFTS WAS FOUND TO BE PHYSICALLY AND STRUCTURALLY NORMAL, NO DEFECTS COULD BE DETECTED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AS TO WHY THIS PARTICULAR GRAFT LEAKED DURING THE PROCEDURE. A LETTER AND REPORT HAVE BEEN SENT TO THE DOCTOR, THE RESPONSE FROM THE DOCTOR WILL BE INCLUDED IN VASCUTEK'S FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE EVENT IS BEING REPORTED DUE TO INTERVENTION BEING REQUIRED TO REPLACE A LEAKING GRAFT, THE EVENT OCCURRED IN (B)(6). THE GELSOFT PLUS GRAFT WAS CUT IN HALF BY THE HOSP, ONE HALF WAS USED FOR AXILLARY REPAIR AND THE OTHER FOR FEMORAL BRANCHES. AFTER DE CLAMPING, BLOOD SPURTED OUT OF 3 POINTS ON THE AXILLARY SECTION, THE LEAKS WERE DESCRIBED AS PIN HOLE LEAKS. NO USE OF FORCEPS IN THE LEAKING AREA WAS REPORTED. THE LEAKING SEGMENT ON THE AXILLARY SIDE WAS REMOVED AND A BRANCH REBUILT WITH A VASCUTEK GELWEAVE GRAFT. THE PT WAS REPORTED TO BE FINE POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELSOFT PLUS VASCULAR PROSTHESIS DSY VASCUTEK LTD. NA 118792/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention