BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO 2/14 200 CM STANDARD

    MDR report key: 4792719 · Received May 22, 2015

    Report

    Report Number
    3008853977-2015-00224
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    April 13, 2015
    Report Date
    April 14, 2015
    Manufacturer
    STRYKER NEUROVASCULAR-UTAH
    Product Code
    DQX
    PMA / PMN Number
    K053268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS PEELED OFF BETWEEN 24.0CM TO 27.0CM FROM ITS PROXIMAL TIP. THE PTFE COATING WAS SCRAPED ON THE GUIDEWIRE. THE PTFE COATING APPEARED TO BE SCRAPED OFF OF THE GUIDEWIRE WITH THE TORQUE DEVICE COLLET. THE TORQUE DEVICE WAS ON THE GUIDEWIRE. NO ANOMALIES WERE OBSERVED WITH THE HYDROPHILIC COATING. THE GUIDEWIRE DIMENSIONS WERE FOUND WITHIN SPECIFICATION. THERE WAS NO FRICTION NOTED DURING FUNCTIONAL TEST WITH A DEMONSTRATION EXCELSIOR SL-10 MICROCATHETER. THE GUIDEWIRE WAS ATTACHED TO A DEMONSTRATION TORQUE DEVICE AND ONE TO ONE TORQUE WAS CHECKED. THE GUIDEWIRE TORQUE WAS SMOOTH. THE DIRECTIONS FOR USE (DFU) CAUTION TO: ¿SECURELY FASTEN THE TORQUE DEVICE ONTO THE WIRE TO PREVENT SLIPPAGE OF THE TORQUE DEVICE AND TO AVOID PRODUCT DAMAGE (I.E., CORE WIRE ABRASION/PEELING OF PTFE, ETC.).¿ THE COATING DAMAGE ON THE PROXIMAL END OF THE GUIDEWIRE WAS PROBABLY DUE TO THE INSUFFICIENT TIGHTENING OF THE TORQUE DEVICE. SINCE THE DEVICE DFU SPECIFICALLY CAUTIONS THAT INSECURE TIGHTENING OF THE TORQUE DEVICE CAN LEAD TO PTFE PEELING, THEREFORE; THE CAUSE IS CONSIDERED TO BE RELATED TO THE DFU INSTRUCTION NOT BEING FOLLOWED.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS PEELING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334138 SYNCHRO 2/14 200 CM STANDARD WIRE, GUIDE, CATHETER DQX STRYKER NEUROVASCULAR-UTAH B36112

    Patients

    Seq Age Sex Outcome Treatment
    1 EXCELSIOR SL-10 MICROCATHETER (STRYKER)