BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD PERIPHERAL VASCULAR

    MDR report key: 813459 · Received February 6, 2007

    Report

    Report Number
    MW1041894
    Event Type
    Injury
    Date Received
    February 6, 2007
    Date of Event
    December 21, 2006
    Report Date
    February 6, 2007
    Manufacturer
    *
    Product Code
    FIQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WENT TO SURGERY FOR INSERTION OF RIGHT AXILLA FEMORAL A-V GRAFT. DEVELOPED HEMATOMA RIGHT GROIN DURING PACU PHASE - RETURNED TO SURGERY- FOUND IMPLANTED GRAFT HAD SPLIT ABOVE THE ANASTOMOSIS SITE. REMAINING GRAFT AT FEMORAL SITE RANGED FROM A FEW MM TO APPROX 13 MM. DECISION MADE TO OVERSAW GRAFT (AND BRING BACK TO OR LATER) WITH 5-0 PROLENE. GRAFT SPLIT AGAIN. RETURNED TO OR THE FOLLOWING DAY FOR REPLACEMENT OF GRAFT. EBL: GREATER THAN 3000 CC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD PERIPHERAL VASCULAR DYNAFLO BYPASS GRAFT FIQ * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening| R