BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET 360 SOFT 3MM X 6CM

    MDR report key: 21060785 · Received January 2, 2025

    Report

    Report Number
    3008881809-2025-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    November 28, 2024
    Report Date
    February 28, 2025
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    HCG
    PMA / PMN Number
    K120850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 MAIN COIL FAILED TO DETACH AND WHEN THE DELIVERY WIRE WAS REMOVED FROM THE POWER SUPPLY, IT WAS DAMAGED/FRACTURED AT THE PROXIMAL END. IT IS LIKELY THAT THIS DAMAGE RESULTED IN THE DETACHMENT ISSUES. NO ANOMALIES WERE NOTED TO THE DEVICE PACKAGING AND THE DELIVERY WIRE DAMAGE WAS NOT NOTED DURING PREPARATION. AN ASSIGNABLE CAUSE OF UNDETERMINABLE WILL BE ASSIGNED TO THIS COMPLAINT AS THE PRODUCT WAS NOT RETURNED AND REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION FAILS TO INDICATE AN ASSIGNABLE CAUSE OR PROBABLE ASSIGNABLE CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING EMBOLIZATION PROCEDURE OF UNRUPTURED CEREBRAL ANEURYSM, AFTER THE SUBJECT COIL WAS IMPLANTED AS THE FIRST COIL, THE PROXIMAL END OF THE DELIVERY WIRE WAS INSERTED INTO THE FUNNEL OF THE POWER SUPPLY; HOWEVER, THE SYSTEM READY INDICATOR DID NOT LIT. SEVERAL ATTEMPTS WITH NO IMPROVEMENT, THE POWER SUPPLY WAS REPLACED WITH A NEW ONE. THE SYSTEM READY INDICATOR LIT GREEN ON THE SECOND POWER SUPPLY, AND DETACHMENT CYCLE WAS PERFORMED; HOWEVER, THE ABOVE SUBJECT COIL COULD NOT BE DETACHED ALTHOUGH SEVERAL ATTEMPTS WERE MADE. THUS, CHECKED THE DELIVERY WIRE, AND FOUND THAT THE PROXIMAL END WAS BENT AND THE WIRE ITSELF SEEMED TO BE FRACTURED, SO THE SUBJECT COIL WAS REMOVED FROM THE BODY AND REPLACED IT WITH A NEW ONE. ALTHOUGH THE SYSTEM READY INDICATOR BECAME GREEN ON THE SECOND POWER SUPPLY, THE LIGHT WAS ON AND OFF AND NOT STABLE, SO THE FRACTURED PART OF THE COIL (PROXIMAL OF THE DELIVERY WIRE) MIGHT HAD BEEN INSIDE OF THE POWER SUPPLY. THEREFORE, THE SECOND POWER SUPPLY WAS ALSO REPLACED WITH A NEW ONE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING EMBOLIZATION PROCEDURE OF UNRUPTURED CEREBRAL ANEURYSM, AFTER THE SUBJECT COIL WAS IMPLANTED AS THE FIRST COIL, THE PROXIMAL END OF THE DELIVERY WIRE WAS INSERTED INTO THE FUNNEL OF THE POWER SUPPLY; HOWEVER, THE SYSTEM READY INDICATOR DID NOT LIT. SEVERAL ATTEMPTS WITH NO IMPROVEMENT, THE POWER SUPPLY WAS REPLACED WITH A NEW ONE. THE SYSTEM READY INDICATOR LIT GREEN ON THE SECOND POWER SUPPLY, AND DETACHMENT CYCLE WAS PERFORMED; HOWEVER, THE ABOVE SUBJECT COIL COULD NOT BE DETACHED ALTHOUGH SEVERAL ATTEMPTS WERE MADE. THUS, CHECKED THE DELIVERY WIRE, AND FOUND THAT THE PROXIMAL END WAS BENT AND THE WIRE ITSELF SEEMED TO BE FRACTURED, SO THE SUBJECT COIL WAS REMOVED FROM THE BODY AND REPLACED IT WITH A NEW ONE. ALTHOUGH THE SYSTEM READY INDICATOR BECAME GREEN ON THE SECOND POWER SUPPLY, THE LIGHT WAS ON AND OFF AND NOT STABLE, SO THE FRACTURED PART OF THE COIL (PROXIMAL OF THE DELIVERY WIRE) MIGHT HAD BEEN INSIDE OF THE POWER SUPPLY. THEREFORE, THE SECOND POWER SUPPLY WAS ALSO REPLACED WITH A NEW ONE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115379 TARGET 360 SOFT 3MM X 6CM DEVICE, NEUROVASCULAR EMBOLIZATION HCG STRYKER NEUROVASCULAR CORK 24109127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown INZONE (STRYKER)