BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM GUIDEWIRE

    MDR report key: 2153721 · Received July 7, 2011

    Report

    Report Number
    2134265-2011-02843
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 8, 2011
    Manufacturer
    BOSTON SCIENTIFIC - FREMONT
    Product Code
    DQX
    PMA / PMN Number
    K050964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR#: 2134265-2011-02844. IT WAS REPORTED THAT DURING A PERIPHERAL TREATMENT PROCEDURE, THE CATHETER BECAME STUCK ON THE GUIDE WIRE. THE PATIENT WAS UNDERGOING AN ENDO LEAK REPAIR OF A STENT GRAFT IN THE AORTA-ILIAC ARTERY. THE RENEGADE FIBER BRAIDED MICROCATHETER BECAME STUCK DURING INITIAL ADVANCEMENT OVER THE FATHOM GUIDE WIRE. THE DEVICES WERE REMOVED TOGETHER AS A UNIT. THE PROCEDURE WAS COMPLETED AFTER EXCHANGING EACH DEVICE FOR ANOTHER OF THE SAME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FATHOM GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - FREMONT M001509100 B21151

    Patients

    Seq Age Sex Outcome Treatment
    1 RENEGADE FIBER BRAIDED MICROCATHETER