BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 1953195 · Received January 7, 2011

    Report

    Report Number
    2015691-2011-14631
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    November 15, 2010
    Report Date
    November 25, 2010
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DXE
    PMA / PMN Number
    K892410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED DEFECT OF BALLOON BURST WAS NOT CONFIRMED. THE BALLOON LATEX AND DISTAL WINDINGS HAVE BEEN PULLED OFF THE DISTAL TIP OF THE CATHETER, AND WERE NOT RETURNED. THE PROXIMAL WINDINGS APPEAR TO BE IN GOOD CONDITION. IT APPEARS THE LATEX HAS PULLED OUT FROM UNDER THE PROXIMAL WINDINGS AND WAS PULLED OFF THE TIP OF THE CATHETER WITH THE DISTAL WINDINGS. THIS CONDITION MAY OCCUR IF THE MAXIMUM RECOMMENDED PULL FORCE HAS BEEN EXCEEDED. THE MAXIMUM PULL FORCE IS 2.0 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

    AS REPORTED, THERE WAS A BALLOON BURST AND A NEW FOGARTY CATHETER HAD TO BE USED. NO CLINICAL CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER ARTERIAL EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES PR 120805F 58838932

    Patients

    Seq Age Sex Outcome Treatment
    1