BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FATHOM GUIDEWIRE

    MDR report key: 2030025 · Received March 25, 2011

    Report

    Report Number
    2939204-2011-00155
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SALT LAKE CITY
    Product Code
    DQX
    PMA / PMN Number
    K050964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ANALYSIS OF THE RETURNED DEVICE FOUND THE DEVICE WAS SEPARATED 7.8CM FROM THE DISTAL END. THE CORE WIRE, NITINOL TUBING AND PLATINUM COIL WERE ALL SEPARATED. THE PLATINUM COIL WAS ALSO EXTENSIVELY STRETCHED AND TWISTED. FROM THE CONDITION OF THE RETURNED DEVICE, IT APPEARED THAT EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION IT IS MOST LIKELY THAT OPERATIONAL CONTEXT WAS THE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE PHYSICIAN HAD ENCOUNTERED DIFFICULTIES ACCESSING THE LESION IN A NARROW AND HIGHLY CALCIFIED SIDE BRANCH OF THE ILIAC ARTERY WITH OTHER GUIDEWIRES. AFTER SEVERAL ATTEMPTS TO ACCESS THE LESION WITH THE SUBJECT DEVICE IT WAS REPORTED THAT THE DEVICE 'PUSHED INTO THE WALL' AND INTO THE HEAVILY CALCIFIED AREA. THERE WAS NO INJURY TO THE VESSEL. THE DISTAL END BROKE OFF AND WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    THE PHYSICIAN HAD ENCOUNTERED DIFFICULTIES ACCESSING THE LESION IN A NARROW AND HIGHLY CALCIFIED SIDE BRANCH OF THE ILIAC ARTERY WITH OTHER GUIDEWIRES. AFTER SEVERAL ATTEMPTS TO ACCESS THE LESION WITH THE SUBJECT DEVICE IT WAS REPORTED THAT THE DEVICE 'PUSHED INTO THE WALL' AND INTO THE HEAVILY CALCIFIED AREA. THERE WAS NO INJURY TO THE VESSEL. THE DISTAL END BROKE OFF AND WAS REMOVED FROM THE PATIENT WITH THE MICROCATHETER. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FATHOM GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - SALT LAKE CITY M001509100 B20505

    Patients

    Seq Age Sex Outcome Treatment
    1 PROGREAT MICROCATHETER (TERUMO)