BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 1953057 · Received January 7, 2011

    Report

    Report Number
    2015691-2011-14628
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DXE
    PMA / PMN Number
    K892410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED DEFECT OF TIP DETACHED WAS CONFIRMED. THE BALLOON LATEX PROXIMAL AND DISTAL WINDINGS HAVE BEEN PULLED OFF THE CATHETER TIP AND A CLOSER EXAMINATION FOUND THAT A 1.2CM SECTION OF THE CATHETER TIP HAS BROKEN OFF AND NONE OF THE DETACHED COMPONENTS WERE RETURNED. THIS CONDITION MAY OCCUR IF THE MAXIMUM RECOMMENDED PULL FORCE HAS BEEN EXCEEDED. THE MAXIMUM PULL FORCE IS 1.5 LBS (PER DFU). A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    DURING AN EMBOLECTOMY OF THE SUPERFICIAL FEMORAL ARTERY THE TIP DETACHED FROM THE CATHETER. THE PHYSICIAN PERFORMED A CUT DOWN TO RETRIEVE THE TIP. THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER ARTERIAL EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES PR 120804F 58884354

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention