BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 2182956 · Received July 28, 2011

    Report

    Report Number
    2015691-2011-15960
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 17, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE EMBOLECTOMY CATHETER WAS RECEIVED WITHOUT THE STYLET WIRE AND PACKAGING. THE REPORTED CUSTOMER COMPLAINT "CATHETER TIP WAS BROKEN" WAS CONFIRMED. THE EVALUATION INCLUDED VISUAL EXAMINATION AND NOTATION OF ANY OBSERVED ABNORMALITIES SUCH AS DAMAGED, INCORRECT OR MISSING COMPONENTS. THE BALLOON AND BALLOON WINDINGS WERE VISUALLY INSPECTED AND THE CATHETER TUBE UNDER THE BALLOON LATEX IS BROKEN IN HALF. THE TUBE BREAK WAS AT THE AT THE #3 INFLATION HOLE. THE BALLOON WAS INFLATED AND THERE WERE NO LEAKS. THE REMAINING 3 INFLATION HOLES WERE COLLAPSED. THE PROXIMAL AND DISTAL WINDINGS WERE IN GOOD CONDITION AND THERE WAS NO DAMAGE TO THE CATHETER BODY. THE BALLOON WAS REMOVED FROM THE DISTAL WINDING AREA, AND THE CATHETER TIP WAS FOUND WITHIN THE ALLOWABLE SPECIFICATION. WITHOUT THE STYLET WIRE RETURNED WE ARE UNABLE TO PERFORM A COMPLETE EVALUATION AND DETERMINE A CAUSE FOR THE CATHETER TIP BREAKAGE. AS ROOT CAUSE COULD NOT BE DETERMINED; NO ACTIONS WILL BE TAKEN AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET SPECIFICATION UPON DISTRIBUTION.

    Description of Event or Problem · 1

    AS REPORTED DURING EMBOLECTOMY, THE CATHETER TIP BROKE UNDERNEATH THE BALLOON WHEN INFLATING. THE DOCTOR DIDN'T APPLY UNDUE PRESSURE OR TRACTION TO THE DEVICE. FORTUNATELY, THE BROKEN TIP REMAINED ATTACHED TO THE CATHETER BY THE BALLOON MATERIAL. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ADDITIONAL EFFORT AND NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES, PR 120804F 58942580

    Patients

    Seq Age Sex Outcome Treatment
    1