BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO-14 STRAIGHT 200-35CM

    MDR report key: 20189758 · Received September 11, 2024

    Report

    Report Number
    3012931345-2024-00168
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 21, 2024
    Report Date
    November 13, 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. THE SUBJECT GUIDEWIRE DEVICE WAS RETURNED FOR ANALYSIS AS THE GUIDEWIRE COATING WAS NOTED TO BE DAMAGED AT THE PROXIMAL END. THE CORE WIRE DISTAL END WAS OBSERVED THROUGH THE DISTAL TIP DOME. NO OTHER ANOMALIES WERE NOTED. FUNCTIONAL TESTING WAS NOT PERFORMED AS THE REPORTED PTFE COATING PEELING WAS CONFIRMED DURING THE DEVICE ANALYSIS. THE 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 THE OPERATOR PREPARED AND FLESHED A SUBJECT GUIDEWIRE BUT AFTER SHAPING IT DURING PREPARATION, THE OPERATOR FOUND COATING AT TAIL OF IT PEELED OFF AND METAL WAS EXPOSED. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT A TORQUE DEVICE HAD BEEN USED ON THE SUBJECT GUIDEWIRE. THE SUBJECT GUIDEWIRE DEVICE WAS RETURNED, AND IT WAS CONFIRMED THAT THE GUIDEWIRE PTFE COATING WAS PEELING. 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¿, AS THE ISSUE IS DUE TO HANDLING OF THE PRODUCT OR PORTION OF THE PRODUCT DURING THE CLINICAL PROCEDURE, UPON REMOVAL OF THE PRODUCT FROM THE PACKAGING, OR PREPARATION OF THE PRODUCT PRIOR TO USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE WAS USED FOR THE ACOMA ANEURYSM EMBOLIZATION CASE (WIDTH OF NECK: 6.34MM. DEPTH: 4.73MM. WIDTH OF ANEURYSM NECK: 3.2MM). DURING PREPARATION, AS THE SUBJECT GUIDEWIRE WAS FLUSHED AND AFTER SHAPING, THE PTFE (POLYTETRAFLUOROETHYLENE) COATING AT THE TAIL OF THE SUBJECT GUIDEWIRE WAS PEELED OFF AND METAL WAS EXPOSED. THEREFORE, ANOTHER GUIDEWIRE FROM THE COMPETITOR WAS USED TO COMPLETE THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE WAS USED FOR THE ACOMA ANEURYSM EMBOLIZATION CASE (WIDTH OF NECK: 6.34MM. DEPTH: 4.73MM. WIDTH OF ANEURYSM NECK: 3.2MM). DURING PREPARATION, AS THE SUBJECT GUIDEWIRE WAS FLUSHED AND AFTER SHAPING, THE PTFE (POLYTETRAFLUOROETHYLENE) COATING AT THE TAIL OF THE SUBJECT GUIDEWIRE WAS PEELED OFF AND METAL WAS EXPOSED. THEREFORE, ANOTHER GUIDEWIRE FROM THE COMPETITOR WAS USED TO COMPLETE THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021460 SYNCHRO-14 STRAIGHT 200-35CM WIRE, GUIDE, CATHETER DQX STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY 0000637963 07613252186922

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female ATLAS STENT (STRYKER)| SL10 MICROCATHETER (STRYKER)