BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSMOS-10-AV

    MDR report key: 16240368 · Received January 25, 2023

    Report

    Report Number
    2032493-2023-00537
    Event Type
    Malfunction
    Date Received
    January 25, 2023
    Date of Event
    September 26, 2022
    Report Date
    January 25, 2023
    Manufacturer
    MICROVENTION, INC.
    Product Code
    HCG
    UDI-DI
    00812636025483
    PMA / PMN Number
    K082461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION / B5: ADDITIONAL INFORMATION WAS RECEIVED ON 2/15/2023 THAT INDICATED, THE COIL DETACHED UNINTENTIONALLY AND WAS LEFT IN THE PATIENT. APPROXIMATELY, 2CM OF THE COIL EXTENDS TO THE ICA, FROM C7 TO C2. NO INTERVENTION WAS PERFORMED. THE CASE WAS SUCCESSFULLY COMPLETED. THE PATIENT IS FINE. VISUAL ANALYSIS: THE VISUAL ANALYSIS OF THE RETURNED ITEMS FOUND THE PUSHER RETURNED WITH NO IMPLANT ATTACHED, AND THE HEATER COIL BURNT (IMG A). INVESTIGATION OF THE PUSHER FOUND THE MONOFILAMENT WITH A MUSHROOM SHAPE PROFILE (IMG B), WHICH INDICATES THE IMPLANT WAS SUCCESSFULLY DETACHED FROM THERMAL ACTIVATION. AS THE IMPLANT WAS NOT RETURNED FOR EVALUATION AND NO PROCEDURE IMAGES WERE PROVIDED FOR REVIEW, THIS INVESTIGATION COULD NOT ASSESS THE ALLEGED FORMING ISSUE AND STRETCHED CONDITION OF THE COIL. THE INVESTIGATION OF THE RETURNED COIL SYSTEM FOUND THE PUSHER RETURNED WITH NO IMPLANT ATTACHED. THE IMPLANT WAS NOT RETURNED FOR EVALUATION. THE PUSHER'S HEATER COIL WAS BURNT, AND THE PUSHER'S MONOFILAMENT SHOWED A MUSHROOM PROFILE SHAPE, WHICH INDICATES THAT THE IMPLANT WAS SUCCESSFULLY DETACHED FROM THERMAL ACTIVATION USING A DETACHMENT CONTROLLER. AS THE IMPLANT WAS NOT RETURNED FOR EVALUATION AND NO PROCEDURE IMAGES OF THE IMPLANT WITHIN THE VESSEL WERE PROVIDED FOR REVIEW, THIS INVESTIGATION COULD NOT ASSESS THE ALLEGED FORMING ISSUE AND STRETCHED CONDITION OF THE COIL.

    Additional Manufacturer Narrative · 0

    A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION IS ONGOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED, DURING TREATMENT OF THE POSTERIOR COMMUNICATION ANEURYSM. THE COIL COULD NOT BE FORMED AFTER MULTIPLE ATTEMPTS. THE DOCTOR FOUND THAT THE COIL WAS STRETCHED AND FLOATED OUT OF THE BLOOD VESSEL ABOUT 2CM. THERE WAS NO REPORTED PATIENT INJURY NOR MEDICAL INTERVENTION. THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823496 COSMOS-10-AV COILS-NEUROVASCULAR EMBOLIZATION DEVICE HCG MICROVENTION, INC. 100306CSSR-V-A1-CN 0000126107 00812636025483

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female