BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO-14 STRAIGHT 200-35CM

    MDR report key: 20100291 · Received August 29, 2024

    Report

    Report Number
    3012931345-2024-00156
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    August 5, 2024
    Report Date
    October 31, 2024
    Manufacturer
    STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
    Product Code
    DQX
    UDI-DI
    07613252186922
    PMA / PMN Number
    K002907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 GTIN: CORRECTED TO (B)(4). D4 EXPIRATION DATE - ADDED. D9 PRODUCT AVAILABLE TO STRYKER/ RETURNED TO MANUFACTURER ON ¿UPDATED. G4 PMA/510(K) ¿ CORRECTED TO K002907. H3 DEVICE EVALUATED BY MFG ¿ UPDATED. H4 MANUFACTURING DATE ¿ ADDED. THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. VISUAL INSPECTION OF THE RETURNED SUBJECT GUIDEWIRE REVEALED THAT PTFE COATING WAS NOTED TO BE PEELED AT 64CM TO 73CM FROM THE PROXIMAL END. THE DISTAL END OF THE SUBJECT GUIDEWIRE WAS NOTED TO BE FRACTURED TO THE NITINOL TUBING WITH THE COIL AND CORE WIRE EXPOSED AT 7CM FROM THE DISTAL END (THIS WAS CONFIRMED TO HAVE OCCURRED POST PROCEDURE). THERE WAS DAMAGE/ ROUGHNESS NOTED TO THE DISTAL HYDROPHILIC COATING IN A NUMBER OF LOCATIONS. FUNCTIONAL TEST WAS PERFORMED AS THE SUBJECT GUIDEWIRE WAS HYDRATED AND WHEN FINGERS WERE RAN ALONG THE LENGTH, ROUGHNESS WAS FELT TO THE HYDROPHILIC COATING. THE REPORTED PTFE COATING PEELING WAS CONFIRMED. THE REPORTED DIFFICULT TO ADVANCE THE SUBJECT GUIDEWIRE COULD NOT BE DUPLICATED DUE TO THE DAMAGE NOTED, HOWEVER, THE DAMAGE NOTED IS CONSISTENT WITH THE REPORTED EVENT. THE REPORTED GUIDEWIRE FRACTURE WAS CONFIRMED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. IT WAS REPORTED THAT FLUSHED AND DELIVERED A SUBJECT GUIDEWIRE AND WHEN MANIPULATE IT THE OPERATOR FOUND THE COATING BETWEEN MIDDLE TO TAIL WAS PEELING AND RESISTANCE WAS ENCOUNTERED WHEN DELIVERED IT TOGETHER WITH SL-10 MICROCATHETER. THE OPERATOR THEN WITHDREW THE SUBJECT GUIDEWIRE AND USED ANOTHER ONE TO CONTINUE THE PROCEDURE SUCCESSFULLY. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THE DEVICE WAS PREPARED FOR USE AS PER THE DIRECTIONS FOR USE, THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT, CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE AND THE PATIENTS ANATOMY WAS MODERATELY TORTUOUS. WHEN PACKING THE SUBJECT GUIDEWIRE ON THE TABLE, THE NURSE UNCAREFULLY BROKEN IT TO FRACTURED. THE SUBJECT GUIDEWIRE DEVICE WAS RETURNED AND IT WAS CONFIRMED THAT THE GUIDEWIRE WAS FRACTURED AND THE PTFE COATING WAS PEELING. THE HYDROPHILIC COATING WAS NOTED TO BE ROUGH AND DAMAGED. THE PEELING NOTED TO THE PTFE COATING IS INDICATIVE OF INTERACTION WITH AN UNDER TIGHTENED TORQUE DEVICE. AN ASSIGNABLE CAUSE OF HANDLING DAMAGE WILL BE ASSIGNED TO THE REPORTED AND ANALYZED ¿ GUIDEWIRE PTFE COATING PEELING¿. IT WAS REPORTED THAT THE GUIDEWIRE WAS BROKEN WHEN BEING PACKED POST PROCEDURE, THEREFORE AN ASSIGNABLE CAUSE OF HANDLING DAMAGE WILL BE ASSIGNED TO THE REPORTED AND ANALYZED ¿ GUIDEWIRE BROKEN/FRACTURED DURING PREPARATION¿. THE DAMAGE NOTED TO THE HYDROPHILIC COATING IS INDICATIVE OF ADVANCING THE HYDRATED SUBJECT GUIDEWIRE AGAINST RESISTANCE, AS WAS REPORTED. IT IS POSSIBLE THAT THE PATIENTS TORTUOUS ANATOMY MAY HAVE CAUSED THE REPORTED DIFFICULTY TO ADVANCE THE SUBJECT GUIDEWIRE AND SUBSEQUENT COATING DAMAGE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED ¿ GUIDEWIRE DIFFICULT TO ADVANCE¿ AND TO THE ANALYZED ¿ GUIDEWIRE HYDROPHILIC COATING SURFACE ROUGH¿, AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ANEURYSM PROCEDURE, WHEN MANIPULATING THE SUBJECT GUIDEWIRE, THE COATING OF THE SUBJECT GUIDEWIRE WAS FOUND TO BE PEELING BETWEEN THE MIDDLE TO THE TAIL OF THE SUBJECT GUIDEWIRE AND RESISTANCE WAS ENCOUNTERED WHEN DELIVERING THE SUBJECT GUIDEWIRE TOGETHER WITH THE MICROCATHETER. THE SUBJECT GUIDEWIRE WAS REPLACED WITH A NEW GUIDEWIRE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ANEURYSM PROCEDURE, WHEN MANIPULATING THE SUBJECT GUIDEWIRE, THE COATING OF THE SUBJECT GUIDEWIRE WAS FOUND TO BE PEELING BETWEEN THE MIDDLE TO THE TAIL OF THE SUBJECT GUIDEWIRE AND RESISTANCE WAS ENCOUNTERED WHEN DELIVERING THE SUBJECT GUIDEWIRE TOGETHER WITH THE MICROCATHETER. THE SUBJECT GUIDEWIRE WAS REPLACED WITH A NEW GUIDEWIRE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095953 SYNCHRO-14 STRAIGHT 200-35CM WIRE, GUIDE, CATHETER DQX STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY 0000340273 07613252186922

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male SL-10 MICROCATHETER (STRYKER).