BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON

    MDR report key: 7947295 · Received October 9, 2018

    Report

    Report Number
    2029214-2018-00838
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    October 2, 2018
    Report Date
    February 4, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    KRA
    UDI-DI
    00847536005969
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE ECHELON-10 MICRO CATHETER (MODEL: 190-5091-150 LOT: A548184) WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX. THE ECHELON-10 TOTAL LENGTH WAS MEASURED TO BE APPROXIMATELY 155.2CM (: 155.0CM) AND THE USEABLE LENGTH WAS MEASURED TO BE APPROXIMATELY147.5CM WHICH IS WITHIN SPECIFICATION (SPECIFICATION: 147.0CM ± 1.5CM). UPON VISUAL INSPECTION, NO ISSUES OR IRREGULARITIES WERE FOUND WITH THE ECHELON-10 HUB. NO BENDS OR KINKS WERE FOUND WITH THE ECHELON-10 CATHETER BODY. THE ECHELON-10 MICRO CATHETER DISTAL TIP WAS NOTED PRE-SHAPED. THE ECHELON-10 DISTAL MARKER BAND/TIP WAS FOUND MISSING AND NOT RETURNED. THE WHEREABOUTS OF THE MISSING SEGMENT IS NOT KNOWN. THE OUTER AND INNER TUBING MATERIAL AT THE BROKEN END EXHIBITED WITH JAGGED EDGES AND STRETCHING. THE INNER ELLIPTICAL WIRE AT THE BROKEN END WAS FOUND TO BE EXPOSED. THE ECHELON-10 MICRO CATHETER WAS FLUSHED, WATER EXITED FROM THE DISTAL TIP. AN IN-HOUSE MANDREL WAS INSERTED THROUGH THE ECHELON-10 MICRO CATHETER WITHOUT ISSUE. THE DISTANCE FROM THE DISTAL EDGE OF THE PROXIMAL MARKER BAND TO THE CATHETER DISTAL END WAS MEASURED TO BE 29.1MM WHICH IS NOT WITHIN SPECIFICATION (SPECIFICATION: 31.3MM ± 1.0MM). APPROXIMATELY 2.0MM OF THE DISTAL MARKER BAND/TIP WAS FOUND MISSING. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUS TOMER¿S REPORT OF ¿MARKER BAND DISLODGED¿ WAS CONFIRMED. THE BROKEN END OF THE CATHETER EXHIBITED WITH PLASTIC DEFORMATION (JAGGED EDGES AND STRETCHING) WHICH INDICATED THAT THE CATHETER TIP SEPARATED WHEN EXCEEDING THE TENSILE STRENGTH OF THE TUBING MATERIAL. IT IS POSSIBLE HIGH FORCE WAS USED (PUSHING/PULLING) DURING DELIVERY; SUBSEQUENTLY CAUSING THE CATHETER TIP TO SEPARATE. HOWEVER, THE ROOT CAUSE FOR THE TIP SEPARATION 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

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT WHEN THE MICROCATHETER WAS INSIDE THE ANEURYSM, THE DISTAL MARKING BAND WAS NOT OBSERVED DURING FLUOROSCOPY DUE TO IT BEING DISLODGED/DAMAGED. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THERE WERE NO RELATED PATIENT SYMPTOMS. ANCILLARY DEVICES INCLUDE AN RFXA072-115-08 MICROCATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788604 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 190-5091-150 A548184 00847536005969

    Patients

    Seq Age Sex Outcome Treatment
    1