BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APOLLO

    MDR report key: 7039650 · Received November 16, 2017

    Report

    Report Number
    2029214-2017-01270
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    July 12, 2017
    Report Date
    April 9, 2018
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    MFE
    PMA / PMN Number
    P030004/S006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE MICROCATHETER WAS RETURNED FOR ANALYSIS. NO EMBOLIC RESIDUE WAS FOUND WITHIN THE MICROCATHETER HUB. NO ISSUES WERE FOUND WITH THE MICROCATHETER HUB OR BODY. THE DETACHABLE TIP WAS FOUND TO BE DETACHED FROM THE MICROCATHETER, AND THE TIP WAS NOT RETURNED FOR ANALYSIS. THE MICROCATHETER WAS FLUSHED AND FOUND PATENT. NO OTHER ANOMALIES WERE OBSERVED. IT WAS CONFIRMED THAT THE CORRECT THE MICROCATHETER WAS RETURNED. THE REPORT OF TIP PREMATURE DETACHMENT THE ISSUE WAS CONFIRMED; HOWEVER, THE CAUSE COULD NOT BE DETERMINED. INFORMATION REGARDING THE TIP PREMATURE DETACHMENT WAS NOT PROVIDED. PREMATURE TIP DETACHMENT CAN OCCUR DURING NAVIGATION, DUE TO VESSEL CALCIFICATION (TIP GETS CAUGHT AND DISLODGES), DURING GUIDEWIRE INSERTION, REPOSITIONING OF THE MICRO CATHETER WHILE IT IS IN A WEDGED POSITION OR WITH VESSELS THAT ARE IN VASOSPASM OR IF THE MICRO CATHETER IS REPOSITIONED AFTER THE START OF THE LIQUID EMBOLIC MATERIAL INJECTION. PER THE MICROCATHETER INSTRUCTIONS FOR USE (IFU): ¿ALWAYS HANDLE THE DISTAL END OF THE CATHETER WITH CARE TO AVOID DAMAGE TO THE DETACHMENT ZONE AND UNINTENDED DETACHMENT. NAVIGATING OR REPOSITIONING THE CATHETER WHILE IT IS IN A WEDGED POSITION OR WITH VESSELS THAT ARE IN VASOSPASM MAY CAUSE PREMATURE TIP DETACHMENT. DURING NAVIGATION, CHECK THAT THE DISTAL TIP OF THE CATHETER IS NOT KINKED BEFORE PASSING THE GUIDEWIRE THROUGH IT. KINKING OR PROLAPSING OF THE CATHETER MAY RESULT IN UNINTENDED RUPTURE OF THE CATHETER.¿ ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. LINKED MDR 2029214-2017-01271. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THE APOLLO DETACHABLE TIP DID NOT DETACH WITHIN THE PATIENT BUT WHEN IT WAS IN TRANSIT TO MEDTRONIC. NO INJURY REPORTED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THE CATHETER DETACHABLE TIP UNINTENTIONALLY DETACHED. THE LOCATION OF THE DETACHABLE TIP IS UNKNOWN ("IT'S NOT TRACEABLE"). THE PATIENT WAS RECEIVING LIQUID EMBOLIC EMBOLIZATION TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) IN THE OPHTHALMIC ORIGIN. VESSEL TORTUOSITY WAS MODERATE AND ACCESS VESSEL WAS THE INTERNAL CAROTID ARTERY (ICA) WITH DIAMETER OF 4MM. THE PROCEDURE WAS COMPLETED WITH A NEW CATHETER. NO PATIENT INJURY WAS REPORTED TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816899 APOLLO AGENT, INJECTABLE, EMBOLIC MFE COVIDIEN (IRVINE) 105-5096-000 A402108

    Patients

    Seq Age Sex Outcome Treatment
    1