BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX 014/205 PLATINUM

    MDR report key: 5099306 · Received September 24, 2015

    Report

    Report Number
    3008853977-2015-00388
    Event Type
    Malfunction
    Date Received
    September 24, 2015
    Date of Event
    September 6, 2015
    Report Date
    September 8, 2015
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K971254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE GUIDEWIRE WAS FRACTURED AND RETURNED IN TWO FRAGMENTS: THE PROXIMAL FRAGMENT WAS APPROXIMATELY 60.5CM IN LENGTH AND THE DISTAL FRAGMENT WAS APPROXIMATELY 143.5CM IN LENGTH. THE GUIDEWIRE WAS BENT ON SEVERAL PLACES ALONG ITS LENGTH. THE BENDING ON THE GUIDEWIRE APPEARED TO BE DUE TO EXCESSIVE MANIPULATION. MAGNIFIED EXAMINATION OF THE FRACTURE SITE SHOWED THE CORE WIRE WAS FRACTURED. FROM THE CONDITION OF THE GUIDEWIRE AT THE FRACTURE SITE, IT APPEARS THAT THE GUIDEWIRE WAS BENT FIRST AND THEN SEPARATED. THE FRACTURE ON THE GUIDEWIRE APPEARED TO BE DUE TO THE EXCESSIVE MANIPULATION AND TORSIONAL. BECAUSE THE REPORTED GUIDEWIRE BROKEN/FRACTURE APPEARED TO OCCUR FROM HANDLING WITHOUT DIRECT PATIENT CONTACT DURING THE PROCEDURE, A PROBABLE CAUSE OF HANDLING DAMAGE WAS ASSIGNED. VISUAL INSPECTION OF THE RETURNED GUIDEWIRE FOUND THAT THE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS SCRAPED OFF ON SEVERAL PLACES DISTAL TO THE FRACTURE SITE. THE PTFE COATING APPEARED TO BE SCRAPED OFF OF THE GUIDEWIRE WITH THE TORQUE DEVICE COLLET. THE GUIDEWIRE HYDROPHILIC COATING WAS PRESENT ON THE GUIDEWIRE AND MEETS VISUAL SPECIFICATIONS. THE OBSERVED SCRAPED PTFE COATING IS BELIEVED TO HAVE OCCURRED FROM AN EXCESSIVELY TIGHTENED TORQUE DEVICE. SINCE THE DEVICE THE DIRECTIONS FOR USE (DFU) SPECIFICALLY CAUTIONS THAT EXCESSIVE TIGHTENING OF THE TORQUE DEVICE CAN LEAD TO PTFE ABRASION, THE CAUSE IS CONSIDERED TO BE RELATED TO THE DFU INSTRUCTION NOT BEING FOLLOWED.

    Description of Event or Problem · 1

    THERE WAS RESISTANCE ENCOUNTERED DURING THE GUIDEWIRE INTRODUCTION INTO THE MICROCATHETER AND THE GUIDEWIRE WAS BROKEN IN THE MIDDLE SECTION. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THERE WAS RESISTANCE ENCOUNTERED DURING THE GUIDEWIRE INTRODUCTION INTO THE MICROCATHETER AND THE GUIDEWIRE WAS BROKEN IN THE MIDDLE SECTION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632485 TRANSEND EX 014/205 PLATINUM WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 17559734

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR