BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY ENDOHELIX REMOTE ENDARTERECTOMY

    MDR report key: 2312211 · Received October 14, 2011

    Report

    Report Number
    1220948-2011-00009
    Event Type
    Malfunction
    Date Received
    October 14, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 23, 2011
    Manufacturer
    LEMAITRE VASCULAR
    Product Code
    DWX
    PMA / PMN Number
    K032105
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR THE EVALUATION ON (B)(6) 2011. DURING THE EVALUATION WE FOUND THAT THE SHAFT (OUTER TUBE) OF THE DEVICE WAS BENT AND HELICAL WIRE WAS DETACHED FROM THE TIP. EVEN THOUGH THE ROOT CAUSE OF THE FAILURE REMAINS INCONCLUSIVE, MOST LIKELY, THE DEVICE USED IN THE PROCEDURE HAD BEEN BENT. THE BEND CREATED ADDITIONAL TENSION FOR THE WIRE AND THE WIRE FAILED DUE TO EXCESSIVE FORCE. THE DETACHED WIRE DAMAGED THE PATIENTS' VESSEL. THE SHAFT COULD BE BENT EITHER DURING THE PHYSICIANS' MANIPULATIONS DURING THE PROCEDURE OR DURING THE SHIPPING AND HANDLING OF THE DEVICE PRIOR TO THE PROCEDURE. THE DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT DURING EITHER THE MANUFACTURING OR THE PACKAGING PROCESSES. HOWEVER, WE HAVE INITIATED THE SUPPLIER CORRECTIVE ACTION FOR OUR SUB-CONTRACTOR TO INVESTIGATE THIS ISSUE IN MORE DETAILS AND TAKE CORRECTIVE ACTION TO PREVENT THIS PROBLEM IN THE FUTURE. PLEASE NOTE THAT NO PATIENT DEATH OR INCAPACITATING INJURIES HAPPENED.

    Description of Event or Problem · 1

    PRIMARY PROCEDURE: REMOTE ENDARTERECTOMY. A PATIENT CAME IN WITH OCCLUDED SFA. THE REMOTE ENDARTERECTOMY HAD TO BE CONVERTED TO FEM-POP DUE TO THE PERFORATION OF THE SFA DUE TO ENDOHELIX DEVICE FAILURE. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY ENDOHELIX REMOTE ENDARTERECTOMY ENDOHELIX ENDORE DWX LEMAITRE VASCULAR EN-100-1 FEH1007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other