BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PTFE VASCULAR GRAFTS SOFT >=6MM

    MDR report key: 2093128 · Received April 15, 2011

    Report

    Report Number
    2242352-2011-00267
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 17, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BEING INVESTIGATED. AWAITING PRODUCT RETURN FOR EVAL. IF FURTHER INFO SHOULD BECOME AVAILABLE TO US, WE WILL SUBMIT A F/U REPORT. (COMPLAINT ID NUMBER IS (B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FEMORAL-FEMORAL BYPASS PROCEDURE, USING AN 8 MM EXXCEL SOFT THIN WALL VASCULAR GRAFT, THE GRAFT TORE DURING ANASTOMOSIS WITH A 6-0 PROLENE SUTURE. DURING THIS PROCEDURE, THE SUPPORT COIL MOVED, AT WHICH TIME, THE DEVICE WAS CUT INTO TWO PIECES AND THE PROCEDURE WAS COMPLETED WITH ONE END OF THIS DEVICE. THERE IS NO REPORTED ADVERSE EFFECT TO THE PT. THE PARTICULAR UPN OR BATCH NUMBER OF THE DEVICE USED DURING THE ALLEGED EVENT HAS NOT BEEN REPORTED TO US AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTFE VASCULAR GRAFTS SOFT >=6MM VASCULAR GRAFT DSY MAQUET CARDIOVASCULAR, LLC 493078 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI