BEUDAMED
    FDA Adverse Event Other Summary report: N

    GELSOFT PLUS - BIFURCATE

    MDR report key: 2887639 · Received November 30, 2012

    Report

    Report Number
    9612515-2012-00020
    Event Type
    Other
    Date Received
    November 30, 2012
    Date of Event
    May 24, 2012
    Report Date
    November 26, 2012
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    PMA / PMN Number
    K955230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - NO INSPECTION AND EVAL OF THE DEVICE HAS BEEN POSSIBLE AS THE EXPLANTED SECTION OF GRAFT IS CURRENTLY EN-ROUTE TO VASCUTEK. RESULTS - AS NO PRODUCT IS CURRENTLY AVAILABLE FOR INSPECTION AND EVAL A REVIEW OF THE MFG RECORDS ASSOCIATED WITH THE AFFECTED PRODUCT (GELSOFT PLUS VASCULAR PROSTHESIS, LOT NO 1117411 3020, S/N (B)(4)) WAS UNDERTAKEN; THIS CONFIRMED THAT THE PRODUCT WAS MANUFACTURED WITHIN SPECS. CONCLUSION CODE - NO CONCLUSION CAN BE DRAWN. AS NO PRODUCT HAS BEEN RETURNED FOR INSPECTION AND EVAL TO DATE, THE ROOT CAUSE OF THE REPORTED DEFECT COULD NOT BE ESTABLISHED AT THIS TIME. ONCE THE SECTION OF GRAFT HAS BEEN RETURNED TO VASCUTEK; AND OUR INSPECTION AND EVAL PROCESS IS COMPLETE, A F/U INCIDENT REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VASCUTEK HAS BEEN NOTIFIED OF AN INCIDENT VIA OUR (B)(4) DISTRIBUTOR (VASCUTEK (B)(4)); THAT OCCURRED IN THE (B)(6) ON (B)(6) 2012. OF NOTE VASCUTEK WAS NOT INFORMED OF THE INCIDENT UNTIL (B)(6) 2012. THE INCIDENT WAS DESCRIBED AS FOLLOWS: DR. (B)(6) PERFORMED AN ELECTIVE SURGICAL PROCEDURE TO IMPLANT A GELSOFT PLUS BIFURCATE GRAFT TO A PT. DURING THE PROCEDURE, THE SURGEON ENCOUNTERED POROSITY ISSUES (LEAKAGE) IN THE MAIN BODY AND THE LEFT LEG OF THE GRAFT. THE SURGEON ATTEMPTED TO STOP THE LEAKAGE BY USING ADD'L GAUZE AND BY USING SURGICAL (BIO-GLUE). A SECTION OF THE GRAFT WAS REMOVED AND WILL BE SENT BACK TO VASCUTEK FOR INSPECTION AND EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GELSOFT PLUS - BIFURCATE VASCULAR PROSTHESIS DSY VASCUTEK LTD. NA 117411 3020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention