BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX 014/205 PLATINUM

    MDR report key: 7954606 · Received October 10, 2018

    Report

    Report Number
    3008853977-2018-00057
    Event Type
    Malfunction
    Date Received
    October 10, 2018
    Date of Event
    August 1, 2018
    Report Date
    October 10, 2018
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    UDI-DI
    08714729326267
    PMA / PMN Number
    K971254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE TRANSCEND GUIDEWIRE WAS RETURNED ALONG WITH THE VOLCANO CATHETER. THE TORQUE DEVICE WAS NOT RETURNED. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE GUIDEWIRE WAS KINKED ON ITS POLYTETRAFLUOROETHYLENE (PTFE) SECTION AT APPROXIMATELY 27.0CM FROM ITS DISTAL END. THE GUIDEWIRE WAS ALSO BENT ON ITS PTFE SECTION AT APPROXIMATELY 10.0CM AND 80.0CM FROM ITS PROXIMAL END AND ON SEVERAL OTHER PLACES ALONG ITS LENGTH. THE PTFE WAS SLIGHTLY SCRAPPED ON ITS PROXIMAL SECTION. THE VOLCANO CATHETER WAS BENT IN THE MIDDLE SECTION. THE INFORMATION IN THE EVENT DESCRIPTION STATES THAT WHEN THE CATHETER WAS ADVANCED OVER THE GUIDEWIRE, THE GUIDEWIRE WAS STUCK IN THE MONORAIL PORT AND THE GUIDEWIRE WAS REMOVED FROM THE IVUS CATHETER AND USED IN THE PROCEDURE. IT IS POSSIBLE THAT THE FORCE MAY HAVE BEEN EXERTED ON THE GUIDEWIRE DURING THIS STEP AS WELL AS AT THE TIME OF MANIPULATION DURING THE PROCEDURE. THEREFORE, IT IS LIKELY THAT THE PROCEDURAL FACTORS MENTIONED ABOVE MAY HAVE CAUSED THE ANOMALIES FOUND DURING ANALYSIS. THEREFORE, AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS HAS BEEN ASSIGNED TO OBSERVED GUIDEWIRE KINK AND PEELING.

    Description of Event or Problem · 1

    DURING ANALYSIS OF THE RETURNED PRODUCT, OT WAS FOUND THAT THE GUIDEWIRE POLYTETRAFLUOROETHYLENE (PTFE) WAS PEELED/SCRAPED OFF. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794893 TRANSEND EX 014/205 PLATINUM WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 21617649 08714729326267

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR