BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON

    MDR report key: 22649154 · Received July 29, 2025

    Report

    Report Number
    2029214-2025-01718
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    July 15, 2025
    Report Date
    August 22, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT WHEN FIST COIL INSERTED INTO THE CATHETER, IT STUCK IN THE MIDDLE AND WHEN PULLED, IT WAS BROKEN. THE SECOND COIL WAS INSERTED INTO THE CATHETER, SAME PROBLEM HAPPENED. WHEN WE USE THE THIRD COIL (AXIUM 9X30 3D) IT WAS SUCCESSFUL. THE COILS WERE STUCK IN THE MIDDLE OF THE CATHETER. THE CATHETER WAS NOT DAMAGED. THE COIL WAS DAMAGED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS ALIVE WITH NO INJURY. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT NEUROVASCULAR ABNORMALITIES. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND V ESSEL TORTUOSITY WAS MINIMAL. ANCILLARY DEVICES INCLUDE A ECHELON (MEDTRONIC) 105-5091-150; AVIGO (MEDTRONIC) 103-0606-200 GUIDEWIRE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THE COIL CAME OUT OF THE INTRODUCER SHEATH SMOOTHLY. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO DETACHMENTS ATTEMPTS WERE MADE. THERE WAS NO DAMAGE OBSERVED TO THE PUSHWIRE. THE COIL WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789159 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 105-5091-150 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male