BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTE GUIDEWIRE

    MDR report key: 3033782 · Received April 3, 2013

    Report

    Report Number
    2134265-2013-02690
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQX
    PMA / PMN Number
    K011968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE RETURNED DEVICE PRESENTED NO INDICATIONS OF MISSING RADIO-OPAQUE (R/O) MARKER COILS. THE OUTER SS COIL WRAPS WERE MANIPULATED IN A MANNER THAT UNDER MAGNIFICATION REVEALED NO ISSUES IN THE FLEXIBLE DISTAL TIP REGION AND AT APPROXIMATELY 3.5 AND 5.5CM FROM THE DISTAL TIP. EXAMINATION OF THE PROXIMAL ASPECT OF THE DISTAL SOLDER JOINT REVEALED THE DISTAL MARKER COIL HAD BEEN ATTACHED TO THE DISTAL TIP SOLDER JOINT; HOWEVER, AT THE TIME OF THE FAILURE ANALYSIS WAS NO LONGER SECURED TO THE DISTAL TIP JOINT. THE SPECIMEN DEVICE DOES PRESENT DRIED BIOMATERIAL DEPOSITS WITHIN THE SPACE WOUND/STRETCH COIL REGIONS AND LARGE RADIUS BENDS OVER THE DISTAL 3.75CM. NO OTHER DAMAGE OR INCONSISTENCIES ARE NOTED TO THE SPECIMEN AT THIS TIME. ALL JOINTS OTHERWISE APPEAR TO BE CORRECT AND INTACT BY VISUAL EXAMINATION AND BY NON-DESTRUCTIVE TESTING. EXCEPT WHERE NOTED, THE SPECIMEN DEVICE APPEARS VISUALLY AND DIMENSIONALLY CORRECT." THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS UNABLE TO BE CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE, GUIDEWIRE WAS MISSING MARKER. THERE WERE NO MARKERS ON THE FORTE GUIDEWIRE. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED TREATMENT PROCEDURE, GUIDEWIRE WAS MISSING MARKER. THERE WERE NO MARKERS ON THE FORTE GUIDEWIRE. THE PROCEDURE WAS COMPLETED AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136471 FORTE GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MAPLE GROVE H74934949050

    Patients

    Seq Age Sex Outcome Treatment
    1