BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO-14 STRAIGHT 200-35CM

    MDR report key: 19983651 · Received August 14, 2024

    Report

    Report Number
    3012931345-2024-00152
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    June 3, 2024
    Report Date
    October 28, 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. G4 PMA/510(K) ¿ CORRECTED TO K002907. H4 MANUFACTURING DATE ¿ ADDED. 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 WAS UNABLE TO BE CONFIRMED AND IT CANNOT BE CONFIRMED THAT THE DEVICE MET SPECIFICATION, AS THE SUBJECT GUIDEWIRE 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 PREPARED TO USE A SUBJECT GUIDEWIRE TO BUILD ACCESS BUT DURING DELIVERY THE DISTAL 10CM OF THE SUBJECT GUIDEWIRE FRACTURED (NOT COMPLETELY). REPLACED IT WITH A NEW ONE TO CONTINUE THE PROCEDURE. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATES THAT THE SUBJECT GUIDEWIRE DEVICE WAS PREPARED FOR USE AS PER THE DIRECTIONS FOR USE, THE SUBJECT GUIDEWIRE 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 SEVERELY TORTUOUS. THE SUBJECT GUIDEWIRE DEVICE WAS NOT RETURNED. BASED ON A REVIEW OF THE AVAILABLE INFORMATION, IT IS PROBABLE THAT THE PATIENTS ANATOMY MAY HAVE CAUSED DIFFICULTIES TO ADVANCE THE SUBJECT GUIDEWIRE AND THE SUBSEQUENT THE SUBJECT GUIDEWIRE FRACTURED. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED ¿GUIDEWIRE DISTAL TIP BROKEN/FRACTURED DURING USE¿, 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 ACOMA ANEURYSM PROCEDURE AS THE OPERATOR PREPARED TO USE THE SUBJECT GUIDEWIRE TO BUILD ACCESS BUT DURING DELIVERY THE DISTAL 10CM OF THE SUBJECT GUIDEWIRE WAS FRACTURED (NOT COMPLETELY). THE SUBJECT GUIDEWIRE WAS REPLACED WITH A NEW GUIDEWIRE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ACOMA ANEURYSM PROCEDURE AS THE OPERATOR PREPARED TO USE THE SUBJECT GUIDEWIRE TO BUILD ACCESS BUT DURING DELIVERY THE DISTAL 10CM OF THE SUBJECT GUIDEWIRE WAS FRACTURED (NOT COMPLETELY). THE SUBJECT GUIDEWIRE WAS REPLACED WITH A NEW GUIDEWIRE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. NO OTHER INFORMATION WAS PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517578 SYNCHRO-14 STRAIGHT 200-35CM WIRE, GUIDE, CATHETER DQX STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY 0000619694 07613252186922

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female