BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPTFE CANNULA GRAFT

    MDR report key: 2492468 · Received March 8, 2012

    Report

    Report Number
    9612515-2012-00003
    Event Type
    Other
    Date Received
    March 8, 2012
    Date of Event
    January 26, 2012
    Report Date
    March 8, 2012
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DWF
    PMA / PMN Number
    081560
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VASCUTEK WILL REVIEW THE MFG AND QC RECORDS. NO GRAFT IS AVAILABLE, THEREFORE NO TESTING OF THE DEVICE CAN TAKE PLACE. VASCUTEK WILL TEST GRAFTS FROM FINISHED GOODS STOCK AND WRITE TO THE DOCTOR WITH THE RESULTS. A SUMMARY OF THE RESULTS AND 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 REQUIRED TO REPLACE THE 1ST CANNULA GRAFT, THE EVENT OCCURRED IN WASHINGTON HOSP CENTRE, WASHINGTON DC. THE CANNULA GRAFT IS USED FOR AXILLARY CANNULATION. WHEN THE CANNULA GRAFT WAS IMPLANTED THERE WAS EXCESSIVE BLEEDING. ALSO WHENEVER THERE WAS A SUTURE THERE WAS BLEEDING. A 2ND CANNULA GRAFT HAD TO BE IMPLANTED TO BYPASS THE HOLES FROM THE 1ST CANNULA GRAFT. THE PT HAD TO BE RETURNED TO SURGERY THE NEXT DAY TO CONTINUED BLEEDING AND THE CANNULA GRAFT HAD TO BE REMOVED AND WAS REPLACED WITH AN EDWARDS¿ LIFE SCIENCE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPTFE CANNULA GRAFT VASCULAR PROSTHESIS DWF VASCUTEK LTD. NA P3723/4 3946

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R