BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEPATH?

    MDR report key: 3193242 · Received June 27, 2013

    Report

    Report Number
    2134265-2013-04331
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DQX
    PMA / PMN Number
    K101599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: THE CONTROL UNIT WAS ACTIVATED AND IT WAS NOTED THAT THE BATTERY WAS DEAD. A TEST BATTERY WAS USED TO ACTIVATE THE CONTROL UNIT .THERE WAS NO MOVEMENT OF THE DEVICE ONCE ACTIVATED. THE DEVICE WAS DISMANTLED AND IT WAS NOTED THE DRIVE SHAFT WAS BROKEN. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT LEG INTERVENTION PROCEDURE, THE DEVICE¿S CONTROL UNIT MALFUNCTIONED. A TRUEPATH DEVICE FAILED TO CROSS A TOTAL OCCLUSION IN THE LEFT LEG. THE PHYSICIAN FELT HIGH RESISTANCE; HOWEVER THE LIGHTS ON THE CONTROL UNIT MALFUNCTIONED. ONLY 1 GREEN LIGHT REMAINED ILLUMINATED WHILE THE TIP OF THE DEVICE REACHED HIGH RESISTANCE. THE PHYSICIAN RETRACTED THE DEVICE BACK INTO THE CATHETER AND ABORTED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT LEG INTERVENTION PROCEDURE, THE DEVICE¿S CONTROL UNIT MALFUNCTIONED. A TRUEPATH DEVICE FAILED TO CROSS A TOTAL OCCLUSION IN THE LEFT LEG. THE PHYSICIAN FELT HIGH RESISTANCE; HOWEVER THE LIGHTS ON THE CONTROL UNIT MALFUNCTIONED. ONLY 1 GREEN LIGHT REMAINED ILLUMINATED WHILE THE TIP OF THE DEVICE REACHED HIGH RESISTANCE. THE PHYSICIAN RETRACTED THE DEVICE BACK INTO THE CATHETER AND ABORTED THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294526 TRUEPATH? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - CORK H74939208181650 0012071901

    Patients

    Seq Age Sex Outcome Treatment
    1