BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO-14 STRAIGHT 200-35CM

    MDR report key: 20196458 · Received September 11, 2024

    Report

    Report Number
    3012931345-2024-00171
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    July 22, 2024
    Report Date
    December 12, 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)(6). 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/MICROSCOPIC INSPECTION WAS PERFORMED AS THE SUBJECT GUIDEWIRE WAS SEEN TO BE KINKED/BENT AT THE PROXIMAL SECTION. THE NITINOL TUBBING WAS SEEN TO BE BROKEN FRACTURED 189 AND 192CM FROM THE PROXIMAL END. THE SUBJECT GUIDEWIRE DISTAL TIP WAS SEEN TO BE STRETCHED. THE SUBJECT GUIDEWIRE PTFE (POLYTETRAFLUOROETHYLENE) WAS SEEN TO BE PEELING FROM THE PROXIMAL END UP TO THE APPROX. 20 CM MARK. THE CORE WIRE DISTAL END WAS OBSERVED THROUGH THE DISTAL TIP DOME. A FUNCTIONAL INSPECTION COULD NOT BE PERFORMED DUE TO THE DAMAGE NOTED TO THE SUBJECT GUIDEWIRE DEVICE. THE REPORTED ¿GUIDEWIRE DISTAL TIP BROKEN/FRACTURED DURING USE¿ WAS CONFIRMED DURING ANALYSIS. THE REPORTED ¿GUIDEWIRE TORQUE PROBLEM¿ AND ¿GUIDEWIRE FRICTION¿ COULD NOT BE DUPLICATED DURING DEVICE ANALYSIS; HOWEVER, THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. THE SUBJECT GUIDEWIRE DEVICE FAILED TO MEET SPECIFICATION WHEN RETURNED FOR ANALYSIS. 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, CHECKED AND FLUSHED THE SUBJECT GUIDEWIRE NORMALLY AND WHEN PLACING IT TO REACH DISTAL OF VESSEL, THE OPERATOR FELT BAD MANIPULATION. HE ROTATED THE SUBJECT GUIDEWIRE TAIL, AND THE TIP OF THE SUBJECT GUIDEWIRE WAS NOT MOVED. WITHDREW THE SUBJECT GUIDEWIRE AND FOUND TIP OF IT FRACTURED, NOT COMPLETELY. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE AND THE PATIENTS ANATOMY WAS MODERATELY TORTUOUS. THERE WAS DIFFICULTY ROTATING THE GUIDEWIRE USING THE TORQUE DEVICE, THE SUBJECT GUIDEWIRE WAS TORQUED FOUR TIMES, AND THE SUBJECT GUIDEWIRE TIP WAS SHAPED 45°. ANALYSIS OF THE RETURNED SUBJECT GUIDEWIRE DEVICE CONFIRMED THAT THE SUBJECT GUIDEWIRE DISTAL TIP HAD SUSTAINED FRACTURES TO THE NITINOL TUBING WITH STRETCHING TO THE PLATINUM COIL, THERE WAS SOME KINKING NOTED TO THE GUIDEWIRE WITH SOME PTFE PEELING NOTED TO THE PROXIMAL SECTION. IT IS PROBABLE THAT THE SUBJECT GUIDEWIRE EXPERIENCED DIFFICULTIES TO MANIPULATE AND ADVANCE TO THE INTENDED SITE DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS PRESENT DURING USE, CAUSING DIFFICULTIES TO TORQUE THE GUIDEWIRE AND SUBSEQUENT STITCHING AND FRACTURES TO THE DISTAL NITINOL TUBING. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE AS REPORTED ¿ GUIDEWIRE DISTAL TIP BROKEN/FRACTURED DURING USE¿, ¿GUIDEWIRE TORQUE PROBLEM¿ AND ¿GUIDEWIRE FRICTION¿, AND TO THE AS ANALYZED ¿GUIDEWIRE DISTAL TIP BROKEN/FRACTURED DURING USE¿ AND ¿GUIDEWIRE DISTAL TIP STRETCHED¿, 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. IT IS PROBABLE THAT THE PROXIMAL END OF THE SUBJECT GUIDEWIRE WAS DAMAGED DUE TO HANDLING OF THE SUBJECT GUIDEWIRE DEVICE DURING USE, AND THE PTFE PEELING IS INDICATIVE OF INTERACTION WITH AN UNDER TIGHTENED TORQUE DEVICE OR PERHAPS DURING REMOVAL OF THE TORQUE DEVICE POST PROCEDURE. AN ASSIGNABLE CAUSE OF HANDLING DAMAGE WILL BE ASSIGNED TO THE ANALYZED ¿GUIDEWIRE KINKED/BENT¿ AND ¿GUIDEWIRE PTFE COATING PEELING¿.

    Description of Event or Problem · 0

    IT WAS REPORTS THAT DURING AN ANEURYSM EMBOLIZATION CASE. THE SUBJECT GUIDEWIRE WAS USED TO BUILD ACCESS AS IT WAS CHECKED AND FLUSHED NORMALLY. WHEN PLACING IT TO REACH THE DISTAL OF VESSEL, THE OPERATOR FELT BAD MANIPULATION. THE SUBJECT GUIDEWIRE TAIL WAS ROTATED AS THE TIP WAS NOT MOVED. THE SUBJECT GUIDEWIRE WAS WITHDRAWN, AND THE TIP WAS FOUND TO BE FRACTURED (NOT COMPLETELY). THE SUBJECT GUIDEWIRE WAS REPLACED WITH A NEW GUIDEWIRE AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTS THAT DURING AN ANEURYSM EMBOLIZATION CASE. THE SUBJECT GUIDEWIRE WAS USED TO BUILD ACCESS AS IT WAS CHECKED AND FLUSHED NORMALLY. WHEN PLACING IT TO REACH THE DISTAL OF VESSEL, THE OPERATOR FELT BAD MANIPULATION. THE SUBJECT GUIDEWIRE TAIL WAS ROTATED AS THE TIP WAS NOT MOVED. THE SUBJECT GUIDEWIRE WAS WITHDRAWN, AND THE TIP WAS FOUND TO BE FRACTURED (NOT COMPLETELY). THE SUBJECT GUIDEWIRE WAS REPLACED WITH A NEW GUIDEWIRE AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506681 SYNCHRO-14 STRAIGHT 200-35CM WIRE, GUIDE, CATHETER DQX STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY 0000638443 07613252186922

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male SL-10 MICROCATHETER (STRYKER).