BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELSOFT PLUS

    MDR report key: 4420692 · Received January 13, 2015

    Report

    Report Number
    9612515-2015-00003
    Event Type
    Injury
    Date Received
    January 13, 2015
    Date of Event
    May 12, 2014
    Report Date
    January 13, 2015
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    PMA / PMN Number
    K955230
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED PORTION OF GRAFT HAS BEEN REQUESTED ROM THE DISTRIBUTOR. IF RETURNED, THE AFFECTED SECTION OF THE GRAFT WILL BE EVALUATED AND THE RESULTS WILL BE PROVIDED WITHIN A SUPPLEMENTAL FOLLOW UP REPORT. DEVICE CODE: THE LEAK IN THE GRAFT WAS IDENTIFIED AFTER THE MAIN BODY SECTION WAS CLAMPED DURING THE PROCESS OF ANASTOMOSING ONE OF THE LIMBS. METHOD: ACTUAL DEVICE NOT EVALUATED. THE AFFECTED GRAFT HAS NOT YET BEEN RETURNED TO VASCUTEK LTD., FOR ANALYSIS. VASCUTEK HAS REQUESTED THE RETURN OF THE AFFECTED GRAFT FOR ANALYSIS. DHR, QC AND MANUFACTURING RECORDS FOR BATCH AND BASE FABRIC HAVE BEEN REVIEWED. RESULTS: REVIEW OF QC AND MANUFACTURING RECORDS SHOW BATCH WAS MANUFACTURED TO DESIGNED SPECIFICATION. NO FURTHER COMPLAINTS HAVE BEEN RECEIVED FROM THIS BATCH. NO RESULTS AVAILABLE SINCE NO EVAL WAS PERFORMED. THE AFFECTED GRAFT HAS NOT YET BEEN RETURNED TO VASCUTEK LTD., FOR ANALYSIS. VASCUTEK HAS REQUESTED THE RETURN OF THE AFFECTED GRAFT FOR ANALYSIS. CONCLUSIONS: UNABLE TO CONFIRM COMPLAINT. AS NO DEVICE HAS BEEN RETURNED TO VASCUTEK FOR INVESTIGATION, IT IS NOT POSSIBLE AT THIS STAGE TO CONFIRM DEVICE RELATIONSHIP. DEVICE NOT RETURNED. THE AFFECTED GRAFT HAS NOT YET BEEN RETURNED TO VASCUTEK LTD FOR ANALYSIS. VASCUTEK HAS REQUESTED THE RETURN OF THE AFFECTED PORTION OF THE GRAFT FOR ANALYSIS. CONCLUSION NOT YET AVAILABLE. VASCUTEK ARE UNABLE TO DRAW ANY DEFINITIVE CONCLUSIONS REGARDING THE ROOT CAUSE OF THIS EVENT AT THIS STAGE. AS OF THIS TIME, THERE IS NO EVIDENCE THAT THE REPORTED PON HOLE IN THE GRAFT WAS PRE-EXISTING DEFECT RELATED TO THE MANUFACTURING PROCESS. ALL GRAFTS ARE 100% LEAK TESTED DURING MANUFACTURING, SO THE REPORTED DEFECT WOULD HAVE BEEN IDENTIFIED PRIOR TO RELEASE FOR DISTRIBUTION.

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED TO VASCUTEK LTD., AS FOLLOWS: "BLOOD LEAKED FROM A PIN-HOLE. AFTER ANASTOMOSING THE PROXIMAL, IN ORDER TO ANASTOMOSE THE LEG SEGMENT, THE CUSTOMER RE-CLAMPED THE MAIN BODY, A PIN-HOLE BLOOD LEAK (OD APPROX 4.0 NEEDLE POINT) OCCURRED AT THE SEGMENT SLIGHTLY BELOW THE BIFURCATION WITH NOTHING DONE TO IT. THE LEAKING PART WAS CUT OFF AND REPLACED WITH A DYNAFLO FROM GORE-TEX. NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30589 GELSOFT PLUS GELSOFT PLUS BIFURCATE DSY VASCUTEK LTD. 631608P 306886

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention