BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO-10 STRAIGHT 200CM

    MDR report key: 17931944 · Received October 13, 2023

    Report

    Report Number
    3012931345-2023-00226
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    October 5, 2023
    Report Date
    August 14, 2024
    Manufacturer
    STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
    Product Code
    DQX
    UDI-DI
    07613252187158
    PMA / PMN Number
    K023700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE ADDRESSED THE FDA REQUEST, RECEIVED VIA EMAIL ON 14 JUNE 2024: ¿UPON REVIEW, WE HAVE DETERMINED THAT THE DEVICE IDENTIFICATION INFORMATION ABOUT THE SUSPECT MEDICAL DEVICES CONFLICTS WITH THE DATA SUBMITTED TO THE GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID)." "DISCREPANCIES WERE NOTED IN THE INFORMATION INCLUDED FOR SOME OR ALL OF THE DEVICE IDENTIFICATION FIELDS OF THE ELECTRONIC EQUIVALENT OF THE FDA FORM 3500A COMPARED TO THE INFORMATION INCLUDED FOR THE CORRESPONDING FIELDS IN THE GUDID." "ADDITIONALLY, THE ¿UNIQUE DEVICE IDENTIFIER (UDI) #¿ FIELD ON THE FDA FORM 3500A SHOULD CONTAIN THE ENTIRE UDI NUMBER INCLUDING THE DI AND PI FIELDS, ALL NUMBERS, LETTERS, PARENTHESES, AND SYMBOLS. PLEASE VERIFY THAT YOU HAVE INCLUDED THE ENTIRE UDI IN THE ¿UNIQUE DEVICE IDENTIFIER (UDI) #¿ FIELD ON THE 3500A." WE HAVE REVIEWED THE DEVICE IDENTIFIER (DI) AND CONFIRM THAT IT IS ACCURATE AND IN ALIGNMENT WITH THE HL7 SPECIFICATIONS RELEASED IN 2017. ADDITIONALLY, THE 510(K) NUMBER HAS BEEN CORRECTED FROM K032146 TO K023700 IN ACCORDANCE WITH THE GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID).

    Additional Manufacturer Narrative · 0

    DUE TO THE AUTOMATED MES (MANUFACTURING EXECUTION SYSTEM) SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE WAS NOT AVAILABLE; THEREFORE, A VISUAL INSPECTION AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. 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. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND IT COULD NOT BE DEFINITIVELY DETERMINED IF THE DEVICE FAILED TO MEET SPECIFICATIONS BECAUSE THE PRODUCT WAS NOT RETURNED. IT WAS REPORTED THAT THE SUBJECT GUIDEWIRE DETACHED IN A NON-STRYKER MICROCATHETER DURING CANNULATION. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THERE WERE NO ANOMALIES NOTED TO THE DEVICE DURING INITIAL INSPECTION AND PREPARATION, THE DEVICE WAS PREPARED AS PER THE DFU, THE DISPENSER HOOP WAS FLUSHED BEFORE REMOVING THE GUIDEWIRE AND THERE WAS NO RESISTANCE ENCOUNTERED REMOVING THE GUIDEWIRE FROM THE DISPENSER HOOP, THE GUIDEWIRE TIP WAS NOT SHAPED, CONTINUOUS FLUSH WAS MAINTAINED FOR THE DURATION OF THE PROCEDURE, THE PATIENT'S ANATOMY WAS TORTUOUS, THE INNER DIAMETER OF THE MICROCATHETER WAS 0.013IN, AND A DIFFERENT MICROCATHETER WITH AN INNER DIAMETER OF 0.0165IN WAS USED TO FINISH THE PROCEDURE. WHILE THERE ARE A NUMBER OF POTENTIAL CAUSES FOR THE REPORTED ISSUE, BECAUSE REVIEW OF AVAILABLE INFORMATION FAILED TO IDENTIFY A DEFINITIVE CAUSE AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS, AN ASSIGNABLE CAUSE OF UNDETERMINABLE WAS ASSIGNED TO THIS COMPLAINT. H3 OTHER TEXT : THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CANNULATION, THE TIP OF THE GUIDEWIRE (SUBJECT DEVICE) DETACHED IN A NON-STRYKER MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. THE PATIENT CONDITION FOLLOWING PROCEDURE IS STABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CANNULATION, THE TIP OF THE GUIDEWIRE (SUBJECT DEVICE) DETACHED IN A NON-STRYKER MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. THE PATIENT CONDITION FOLLOWING PROCEDURE IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1969474 SYNCHRO-10 STRAIGHT 200CM WIRE, GUIDE, CATHETER DQX STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY 0000213984 07613252187158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown APOLLO MICROCATHETER (NON-STRYKER).