BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET XL 360 SOFT 5MM X 15CM

    MDR report key: 12278609 · Received August 4, 2021

    Report

    Report Number
    3008881809-2021-00324
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    April 1, 2021
    Report Date
    August 4, 2021
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    UDI-DI
    07613327128291
    PMA / PMN Number
    K153658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE AUTOMATED MES (MANUFACTURING EXECUTION SYSTEM) SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING ANALYSIS, THE COIL DELIVERY WIRE WAS SEEN TO BE KINKED/BENT AND THE MAIN COIL WAS FOUND TO BE PREMATURELY DETACHED/SEPARATED DURING USE. FUNCTIONAL TESTING COULD NOT BE PERFORMED AS THE COIL WAS NOT RETURNED. THE REPORTED EVENT COULD NOT BE CONFIRMED; HOWEVER, THE ANALYSIS RESULTS ARE CONSISTENT WITH THE REPORTED EVENT. 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. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THAT CONTINUOUS FLUSH WAS NOT MAINTAINED THROUGHOUT THE PROCEDURE AND AN INCOMPATIBLE NON-STRYKER MICROCATHETER WAS USED, WHICH IS LIKELY TO HAVE CAUSED THE USER TO EXPERIENCE FRICTION AND CONTRIBUTED TO THE PRODUCT PROBLEM CODES NOTED. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER INDICATED THAT CONTINUOUS FLUSH WAS NOT MAINTAINED THROUGHOUT THE PROCEDURE AND AN INCOMPATIBLE NON-STRYKER MICROCATHETER (0.021 IN) WAS USED, WHICH IS LIKELY TO HAVE CAUSED THE USER TO EXPERIENCE FRICTION AND CONTRIBUTED TO THE PRODUCT PROBLEM CODES NOTED. THE DFU STATES CONTINUOUS FLUSH IS TO BE MAINTAINED THROUGHOUT THE PROCEDURE AND "TARGET DETACHABLE COILS ARE COMPATIBLE WITH STRYKER NEUROVASCULAR 2-TIP MARKER MICROCATHETERS (MIN. INTERNAL DIAMETER 0.41 MM [0.016 IN], MAX. INTERNAL DIAMETER 0.48 MM [0.019 IN]).". THEREFORE, BASED ON THE CURRENT INFORMATION AVAILABLE, THE AS REPORTED ISSUE OF 'COIL IN CATHETER FRICTION' AND AS ANALYZED ' MAIN COIL PREMATURELY DETACHED/SEPARATED DURING USE' WILL BE ASSIGNED 'USER ERROR'. AN ASSIGNABLE CAUSE OF HANDLING DAMAGE WILL BE ASSIGNED TO THE 'COIL DELIVERY WIRE KINKED/BENT' AS IT IS MOST LIKELY THAT THIS DAMAGE TO THE DELIVERY WIRE OCCURRED DUE TO HANDLING OF THE DEVICE DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PROCEDURE WHEN THE SUBJECT COIL DEPLOYMENT OPERATION WAS PERFORMED IN THE BLOOD VESSEL, RESISTANCE WAS FELT AT THE MIDDLE PART AND COULD NOT BE USED. THE PHYSICIAN REMOVED THE SUBJECT COIL AND REPLACED IT WITH ANOTHER COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. ANALYSIS OF THE RETURNED DEVICE FOUND THE MAIN COIL PREMATURELY DETACHED/SEPARATED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175097 TARGET XL 360 SOFT 5MM X 15CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK M0036125150 22438604 07613327128291

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER (NON STRYKER MANUFACTURER)