BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 1387677 · Received July 17, 2008

    Report

    Report Number
    6000002-2006-00416
    Event Type
    Other
    Date Received
    July 17, 2008
    Date of Event
    June 9, 2006
    Report Date
    June 20, 2006
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RETURNED TO THE PRODUCT EVALUATION LABORATORY WITH THE BALLOON LATEX, BOTH PROXIMAL AND DISTAL WINDINGS AND THE SPRING TIP MISSING FROM THE TIP OF THE CATHETER. PLEASE NOTE THAT THE DIRECTIONS FOR USE FOR THE EDWARDS MODEL 120803F FOGARTY EMBOLECTOMY CATHETER CAUTIONS THAT BALLOON RUPTURE AND TIP SEPARATION MAY OCCUR IN SITUATIONS WHERE THE RECOMMENDED PULL FORCE IS EXCEEDED TO REMOVE ADHERENT MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER ARTERIAL EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES 120803F UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention