BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO

    MDR report key: 7114377 · Received December 13, 2017

    Report

    Report Number
    2029214-2017-01346
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    November 17, 2017
    Report Date
    December 13, 2017
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004/S006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MICROCATHETER WAS RETURNED FOR ANALYSIS WITHOUT THE DETACHABLE TIP, AS IT REMAINS WITHIN THE PATIENT. LIQUID EMBOLIC MATERIAL RESIDUE WAS FOUND WITHIN THE MICROCATHETER HUB AND OCCLUDING THE DISTAL LUMEN. NO ISSUES WERE FOUND WITH THE MICROCATHETER HUB. THE ENTIRE SURFACE OF THE MICROCATHETER WAS EXAMINED UNDER MAGNIFICATION. THE MICROCATHETER BODY WAS FOUND TO BE RUPTURED NEAR DISTAL END. THE MICROCATHETER WAS PRESSURIZED WITH WATER AND FOUND NON-PATENT AS THE MICROCATHETER IS LIKELY OCCLUDED WITH THE LIQUID EMBOLIC MATERIAL. THE REMAINING LIQUID EMBOLIC MATERIAL WILL NOT BE RETURNED AS IT WAS CONSUMED IN THE EVENT. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE REPORTED INFORMATION, THERE IS NO EVIDENCE SUGGESTING THAT THE MICROCATHETER OR THE LIQUID EMBOLIC MATERIAL WERE DEFECTIVE, BUT RATHER A PROCEDURE RELATED EVENT. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE REPORT OF RUPTURE WAS CONFIRMED, AS THE RETURNED MICROCATHETER WAS FOUND TO BE RUPTURED. HOWEVER, THE CAUSE COULD NOT BE DETERMINED. THE RETURNED MICROCATHETER APPEARED TO HAVE RUPTURED DUE TO OVER-PRESSURIZATION, RESULTING IN PRESSURES EXCEEDING THE LIMITS OF THE MICRO CATHETER. RUPTURE CAN OCCUR DURING INJECTION OF EMBOLIC MATERIAL OR WHEN THE DISTAL PORTION OF THE CATHETER IS KINKED, PROLAPSED, OR OCCLUDED. RUPTURE CAN ALSO OCCUR DUE TO INJECTION RATE, PAUSES DURING INJECTION, USE OF PALM OF HAND PRESSURE OR INCREASED INJECTION FORCE AGAINST RESISTANCE. THE INJECTION RATE WAS FOLLOWED AS INDICATED IN THE IFU. THERE WAS NO RESISTANCE WHEN THE LIQUID EMBOLIC MATERIAL WAS INJECTED. THE USER PAUSED DURING THE INJECTION; HOWEVER, THE DURATION WAS NOT REPORTED. INFORMATION REGARDING USE OF PALM OF HAND PRESSURE DURING INJECTION WAS NOT REPORTED. THE LOT HISTORY RECORD SHOWED NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE. ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. PER THE MICROCATHETER INSTRUCTIONS FOR USE (IFU): ¿INFUSION PRESSURE WITH THIS DEVICE SHOULD NOT EXCEED (B)(4). PRESSURE IN EXCESS OF (B)(4) MAY RESULT IN CATHETER RUPTURE, POSSIBLY RESULTING IN PATIENT INJURY. LINKED MDRS: 2029214-2017-01346 2029214-2017-01347.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THAT THE CATHETER RUPTURE DURING THE LIQUID EMBOLIC MATERIAL INJECTION. DURING AN ARTERIOVENOUS FISTULA EMBOLIZATION PROCEDURE, THE LIQUID EMBOLIC MATERIAL WAS BEING INJECTED, IT WAS FLOWING AS EXPECTED TO THE TARGET REGION WHEN THE CATHETER RUPTURED PROXIMAL TO THE TARGET LESION. THE LIQUID EMBOLIC MATERIAL WAS REPORTED TO HAVE LEAKED INTO THE EXTERNAL INTERNAL CAROTID ARTERY (ICA) VESSEL. HOWEVER, THIS EVENT DID NOT REQUIRE MEDICAL INTERVENTION. THE DETACHABLE TIP WAS REPORTED TO BE IN THE MIDDLE MENINGEAL. NO PATIENT INJURY WAS REPORTED TO HAVE OCCURRED. THE ANATOMY WAS SEVERELY TORTUOUS. THERE WAS NO RESISTANCE WHEN THE LIQUID EMBOLIC MATERIAL WAS INJECTED. THE TIP DETACHED AS INTENDED. THE TIP WAS EMBEDDED IN THE EMBOLIC MATERIAL CAST. THERE WERE PAUSES TO BUILD A PLUG TO DELIVER THE LIQUID EMBOLIC MATERIAL APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    894357 APOLLO AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-5095-000 A408094

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR