BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON

    MDR report key: 8078006 · Received November 16, 2018

    Report

    Report Number
    2029214-2018-00946
    Event Type
    Malfunction
    Date Received
    November 16, 2018
    Date of Event
    October 23, 2018
    Report Date
    January 10, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA
    Product Code
    KRA
    UDI-DI
    00847536005969
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ECHELON-10 MICRO CATHETER (MODEL: 105-5091-150 LOT: A688402) WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX; WITHIN AN OPENED ECHELON-10 MICRO CATHETER CARTON; WITHIN AN OPENED ECHELON-10 MICRO CATHETER INNER POUCH AND WITHIN A DISPENSER TRACK. NO ANCILLARY DEVICES WERE RETURNED; THEREFORE, DEVICE COMPATIBILITY COULD NOT BE ASSESSED. TTHE ECHELON-10 TOTAL LENGTH WAS MEASURED TO BE APPROXIMATELY 155.0CM (REFERENCE: 155.0CM). THE ECHELON-10 USEABLE LENGTH WAS MEASURED TO BE APPROXIMATELY 146.9CM WHICH IS WITHIN SPECIFICATION (SPECIFICATION: 147.0CM ± 1.5CM). UPON VISUAL INSPECTION, NO ISSUES WERE FOUND WITH THE ECHELON-10 MICRO CATHETER HUB OR BODY. THE ECHELON-10 MICRO CATHETER DISTAL TIP APPEARED TO BE SHAPED. THE DISTAL TIP WAS FOUND TO BE DAMAGED. UPON FURTHER INSPECTION THERE APPEARED TO BE A PUNCTURE AT THE DISTAL MARKER BAND. THE ECHELON-10 MICRO CATHETER WAS FLUSHED, WATER EXITED FROM THE PUNCTURE AND THE DISTAL TIP. ONE IN HOUSE X-PEDION-10 GUIDEWIRE (MODEL: 103-0605-200 LOT: 9580541) WAS HYDRATED PER THE HYDROPHILIC GUIDEWIRE IFU. THE IN-HOUSE X-PEDION-10 GUIDEWIRE WAS INSERTED INTO THE ECHELON-10 MICRO CATHETER HUB AND CATHETER LUMEN. NO RESISTANCE WAS ENCOUNTERED; HOWEVER, THE MANDREL WAS UNABLE TO PASS THROUGH THE DISTAL TIP AS IT EXITED THROUGH THE PUNCTURED LOCATION. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿CATHETER PUNCTURE¿ WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    SEE RELATED REGULATORY REPORT 2029214-2018-00945. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT OF ECHELON CATHETER BREAK DURING PREPARATION. IT WAS REPORTED THAT AN ECHELON MICROCATHETER WAS OPENED AND PREPARED. DURING SHAPING, THE MICROCATHETER TIP WAS FOUND TO BE 'RUPTURED'. A NEW ECHELON MICROCATHETER WAS OPENED AND THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916737 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA 105-5091-150 A688402 00847536005969

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR