BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEPATH?

    MDR report key: 3242319 · Received July 23, 2013

    Report

    Report Number
    2134265-2013-04907
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DQX
    PMA / PMN Number
    K101599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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 PREPARATION FOR A CHRONIC TOTAL OCCLUSION (CTO) PROCEDURE, A GUIDE WIRE TIP DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A TRUE PATH GUIDE WIRE WAS SELECTED, THE PHYSICIAN TRIED TO BEND THE TIP OF THE GUIDE WIRE USING THE BENDING TOOL; HOWEVER, THE GUIDE WIRE BECAME STUCK IN THE BEND TOOL AND BENT TOO FAR AND BROKE THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343294 TRUEPATH? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - CORK H74939208181650 0012040402

    Patients

    Seq Age Sex Outcome Treatment
    1