BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHRO-14 STRAIGHT 300-35CM

    MDR report key: 20181234 · Received September 10, 2024

    Report

    Report Number
    3012931345-2024-00167
    Event Type
    Injury
    Date Received
    September 10, 2024
    Date of Event
    August 15, 2024
    Report Date
    November 14, 2024
    Manufacturer
    STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
    Product Code
    DQX
    UDI-DI
    07613252186946
    PMA / PMN Number
    K002907
    Adverse Event
    Yes
    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). G4 PMA/510(K): CORRECTED TO K002907. THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT GUIDEWIRE DEVICE IS NOT AVAILABLE; THEREFORE, A VISUAL INSPECTION AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. THE REPORTED EVENT CANNOT BE CONFIRMED AND IT CANNOT BE CONFIRMED THAT THE DEVICE MET SPECIFICATION, AS THE DEVICE WAS NOT RETURNED. 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 THE OPERATOR USED THE SUBJECT GUIDEWIRE TO SUPER SELECTED THE STENOSIS LESION. THE PATIENT'S VESSEL WAS EXTREMELY TORTUOUS AND DIFFUSE CALCIFICATION SO THE GUIDEWIRE WAS HARD TO BE ADVANCED. THE OPERATOR DECIDED TO FINISH THE PROCEDURE DIRECTLY BUT WHEN RETRACTING THE SUBJECT GUIDEWIRE , THE SUBJECT GUIDEWIRE GOT FRACTURED FOR ABOUT 15CM. THE OPERATOR TRIED TO USE SNARE TO CATCH THE FRACTURED GUIDEWIRE BUT THE VESSEL WAS TOO TORTUOUS SO THE OPERATOR WAS AFRAID IT MAY RESULT IN OTHER COMPLICATION SO AFTER EVALUATION THE OPERATOR DECIDED NOT TO TAKE THE FRACTURED GUIDEWIRE OUT AND FINISHED THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THAT THE PATIENT'S ANATOMY WAS SEVERELY TORTUOUS AND THERE WAS SOME RESISTANCE ENCOUNTERED WHEN ROTATING, THE SUBJECT GUIDEWIRE WAS TORQUED 3-4 TIMES. IT IS PROBABLE THAT THE SUBJECT GUIDEWIRE EXPERIENCED DIFFICULTIES DURING NAVIGATION THROUGH THE PATIENT'S TORTUOUS ANATOMY, WHICH MAY HAVE LED TO DIFFICULTIES WHILE TORQUEING THE GUIDEWIRE AND SUBSEQUENT THE SUBJECT GUIDEWIRE FRACTURE. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED EVENT, 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 AN INTRACRANIAL ATHEROSCLEROSIS DISEASE (ICAD) PROCEDURE, THE SUBJECT GUIDEWIRE WAS USED TO SUPER SELECTED THE STENOSIS LESION. THE PATIENT'S VESSEL WAS EXTREMELY TORTUOUS AND DIFFUSE CALCIFICATION; THEREFORE, THE SUBJECT GUIDEWIRE WAS HARD TO BE ADVANCED. THE OPERATOR DECIDED TO FINISH THE PROCEDURE DIRECTLY BUT WHEN RETRACTING THE SUBJECT GUIDEWIRE, IT WAS FRACTURED ABOUT 15CM. THE OPERATOR TRIED TO USE A SNARE DEVICE TO RETRIEVE THE FRACTURED FRAGMENT BUT THE VESSEL WAS TOO TORTUOUS SO THE OPERATOR WAS AFRAID IT MAY RESULT IN OTHER COMPLICATION SO AFTER EVALUATION THE OPERATOR DECIDED NOT TO TAKE THE FRACTURED GUIDEWIRE OUT AND FINISHED THE PROCEDURE. THERE WAS A SURGICAL DELAY OF 30 MINUTES. BASED ON THE PHYSICIAN¿S OPINION, THE PATIENT'S VESSEL WAS VERY TORTUOUS AS THE SUBJECT GUIDEWIRE FRACTURED WAS ANTICIPATED. THE CURRENT CONDITION OF THE PATIENT IS GOOD AND THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INTRACRANIAL ATHEROSCLEROSIS DISEASE (ICAD) PROCEDURE, THE SUBJECT GUIDEWIRE WAS USED TO SUPER SELECTED THE STENOSIS LESION. THE PATIENT'S VESSEL WAS EXTREMELY TORTUOUS AND DIFFUSE CALCIFICATION; THEREFORE, THE SUBJECT GUIDEWIRE WAS HARD TO BE ADVANCED. THE OPERATOR DECIDED TO FINISH THE PROCEDURE DIRECTLY BUT WHEN RETRACTING THE SUBJECT GUIDEWIRE, IT WAS FRACTURED ABOUT 15CM. THE OPERATOR TRIED TO USE A SNARE DEVICE TO RETRIEVE THE FRACTURED FRAGMENT BUT THE VESSEL WAS TOO TORTUOUS SO THE OPERATOR WAS AFRAID IT MAY RESULT IN OTHER COMPLICATION SO AFTER EVALUATION THE OPERATOR DECIDED NOT TO TAKE THE FRACTURED GUIDEWIRE OUT AND FINISHED THE PROCEDURE. THERE WAS A SURGICAL DELAY OF 30 MINUTES. BASED ON THE PHYSICIAN¿S OPINION, THE PATIENT'S VESSEL WAS VERY TORTUOUS AS THE SUBJECT GUIDEWIRE FRACTURED WAS ANTICIPATED. THE CURRENT CONDITION OF THE PATIENT IS GOOD AND THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251439 SYNCHRO-14 STRAIGHT 300-35CM WIRE, GUIDE, CATHETER DQX STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY 0000452591 07613252186946

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown Required Intervention| O SL-10 MICROCATHETER (STRYKER).