BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ARTERIAL EMBOLECTOMY CATHETER

    MDR report key: 2061576 · Received April 18, 2011

    Report

    Report Number
    2015691-2011-15250
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    December 21, 2010
    Report Date
    March 21, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DXE
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE FOGARTY CATHETER WAS RETURNED WITHOUT THE PACKAGING. THE REPORTED DEFECT WAS CONFIRMED FOR "BALLOON BROKE, INNER WIRE EXPOSED". THE EVALUATION INCLUDED VISUAL EXAMINE, AND NOTE ANY OBSERVED ABNORMALITIES SUCH AS DAMAGED, INCORRECT OR MISSING COMPONENTS. THE BALLOON AND BALLOON WINDINGS/BONDS WERE VISUALLY INSPECTED FOR INDICATION OF DAMAGE OR ABNORMALITY. THE CATHETER WAS CONFIRMED TO BE MISSING PART OF THE BALLOON LATEX, DISTAL WINDINGS AND PART OF THE SPRING TIP, AND THEY WERE NOT RETURNED. THE PROXIMAL WINDINGS WERE FOUND TO BE IN GOOD CONDITION. THIS CONDITION MAY OCCUR WHEN A PULL FORCE OF 0.7 LBS (PER IFU) HAS BEEN EXCEEDED. ALTHOUGH THE REPORTED DEFECT WAS CONFIRMED FOR "BALLOON BROKE, INNER WIRE EXPOSED", THERE IS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT; 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

    IT WAS REPORTED THAT THE BALLOON BROKE; INNER WIRE EXPOSED AND WAS BLOCKED IN THE ANTERIOR TIBIAL ARTERY. THE USER HAD TO PROLONG THE INCISION TO TAKE OUT THE BROKEN BALLOON AND THE WIRE, WHICH CAUSE LIGATION OF THE ARTERY AND "AGGREGATION" (ASSUMED AGGRAVATION) OF THE LIMB ISCHEMIA. THE PATIENT WAS DISCHARGED AND PATIENT MAY REQUIRE ADDITIONAL SURGERY FOR AN EXISTING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ARTERIAL EMBOLECTOMY CATHETER EMBOLECTOMY CATHETER DXE EDWARDS LIFESCIENCES, PR 120803F 58826696

    Patients

    Seq Age Sex Outcome Treatment
    1