BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO

    MDR report key: 21683777 · Received March 24, 2025

    Report

    Report Number
    2029214-2025-00756
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    January 21, 2025
    Report Date
    March 24, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    MFE
    PMA / PMN Number
    P030004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS #(B)(4): EQUIPMENT USED: VIS (M-78210). DRAWING(S) REFERENCED: NONE AS FOUND CONDITION: THE APOLLO CATHETER WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX, A PLASTIC POUCH, AN OPENED OUTER CARTON (B781338), AND AN OPENED INNER POUCH (B781338). DAMAGE LOCATION DETAILS: NO DAMAGES WERE FOUND WITH THE APOLLO CATHETER HUB. NO BENDS OR KINKS WERE FOUND WITH THE APOLLO CATHETER BODY. THE APOLLO CATHETER DISTAL TIP WAS FOUND DETACHED FROM THE CATHETER. THE DETACHED DISTAL TIP WAS NOT RETURNED. TESTING/ANALYSIS: THE APOLLO CATHETER WAS FLUSHED, WATER EXITED FROM THE DISTAL END. AN IN-HOUSE MANDREL WAS INSERTED THROUGH THE APOLLO CATHETER WITHOUT ISSUE. CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S ¿CATHETER RESISTANCE¿ REPORT COULD NOT BE CONFIRMED. NO ISSUES WERE ENCOUNTERED DURING TESTING. THE HYBRID 008 GUIDEWIRE USED IN THE EVENT WAS NOT RETURNED. IN ADDITION, THE DETACHED APOLLO CATHETER DISTAL TIP WAS NOT RETURNED. THEREFORE, AN ANALYSIS OF THE GUIDEWIRE AND DETACHED DISTAL TIP COULD NOT BE PERFORMED AND ANY CONTRIBUTING FACTORS COULD NOT BE ASSESSED. 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

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A MALFORMATION USING AN APOLLO CATHETER 5.0CM, THE HYBRID 008 J MICROGUIDEWIRE COULD NOT BE ADVANCED THROUGH THE MICROCATHETER. THE PROCEDURE INVOLVED ACCESS FROM THE FEMORAL ARTERY, AND THE VESSEL TORTUOSITY WAS NORMAL. THE DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE APOLLO CATHETER WAS REPLACED. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THE RESISTANCE WAS IN THE MIDDLE OF THE CATHETER. CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). EVERYTHING WAS DONE ACCORDING TO PROCEDURE. NO DAMAGE WAS OBSERVED TO THE CATHETER OR GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804128 APOLLO AGENT, INJECTABLE, EMBOLIC MFE MICRO THERAPEUTICS, INC. DBA EV3 105-5097-000 B781338

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female