BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON

    MDR report key: 8084174 · Received November 19, 2018

    Report

    Report Number
    2029214-2018-00950
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    October 24, 2018
    Report Date
    January 2, 2019
    Manufacturer
    COVIDIEN (IRVINE)
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ECHELON-10 MICRO CATHETER WAS RETURNED FOR ANALYSIS. THE ECHELON-10 MICRO CATHETER WAS MEASURED TO BE WITHIN SPECIFICATION. UPON VISUAL INSPECTION, NO ISSUES OR IRREGULARITIES WERE FOUND WITH THE ECHELON-10 MICRO CATHETER HUB. NO KINKS WERE FOUND WITH THE ECHELON-10 MICRO CATHETER BODY. THE ECHELON-10 MICRO CATHETER DISTAL TIP WAS NOTED PRE-SHAPED. THE ECHELON-10 MICRO CATHETER DISTAL TIP WAS FOUND TO BE SEPARATED. THE OUTER AND INNER TUBING MATERIAL AT THE BROKEN END EXHIBITED WITH JAGGED EDGES AND STRETCHING. THE INNER ELLIPTICAL WIRE AT THE DISTAL BROKEN END WAS FOUND TO BE EXPOSED. APPROXIMATELY 2.0MM OF THE DISTAL TIP AND MARKER BAND WERE FOUND MISSING. THE DISTAL TIP AND MARKER BAND WERE RETURNED. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE REPORT OF ¿MARKER BAND DISLODGE¿ WAS CONFIRMED AS A PORTION OF THE DISTAL TIP AND MARKER BAND WERE FOUND MISSING. HOWEVER, THE CAUSE FOR THE SEPARATION COULD NOT BE DETERMINED. THE SEPARATED END OF THE ECHELON-10 MICRO CATHETER EXHIBITED JAGGED EDGES AND STRETCHING WHICH INDICATE THAT THE CATHETER SEPARATED WHEN EXCEEDING THE TENSILE STRENGTH OF THE TUBING MATERIAL. IT IS POSSIBLE THE ECHELON-10 MICRO CATHETER BECAME DAMAGED UPON REMOVAL FROM THE PACKAGING OR IF THE GUIDE WIRE IS ADVANCED PAST THE TIP OF THE MICRO CATHETER (OUTSIDE PATIENT BODY) SUBSEQUENTLY CAUSING THE TIP TO SEPARATE DURING INSERTION INTO THE HEMOSTATIC SIDE ARM ADAPTER. THE PRE-SHAPED ECHELON-10 MICRO CATHETERS INCLUDE A SPLIT INTRODUCER TO AID IN INSERTION INTO THE HEMOSTATIC SIDE ARM ADAPTER. IT WAS NOT REPORTED IF THE SPLIT INTRODUCER WAS USED DURING THE EVENT. THE LOT HISTORY RECORD REVIEW OF THE REPORTED LOT NUMBER SHOWED NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EXPERIENCE. IN ADDITION, ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. PER THE ECHELON INSTRUCTIONS FOR USE (IFU): MODEL NUMBER 190-5091-150, ARE PROVIDED IN A TRAY WITH LID, AND THE CATHETER TIP IS HELD WITHIN THE GROOVE OF A CURVE RETAINER. TO OPEN THE TRAY, LIFT THE LID AT THE CORNER OF THE TRAY WITH THE CATHETER HUB. THE CATHETER AND CURVE RETAINER MAY BE REMOVED FROM THE TRAY TOGETHER. TO FREE THE CATHETER TIP FROM THE CURVE RETAINER, PINCH TWO OPPOSITE CORNERS BACK. THIS OPENS THE GROOVE. LIFT THE CATHETER TIP OUT OF THE GROOVE. INSPECT THE CATHETER PRIOR TO USE TO VERIFY THAT IT IS UNDAMAGED. CAREFULLY INSERT GUIDEWIRE INTO THE HUB OF THE MICRO CATHETER AND ADVANCE GUIDEWIRE INTO THE CATHETER LUMEN. MODEL NUMBER 190-5091-150, INCLUDE A SPLIT INTRODUCER TO AID IN INSERTION INTO THE HEMOSTATIC SIDE ARM ADAPTER. TO USE, SLIDE THE SPLIT INTRODUCER FROM THE PROXIMAL END UNTIL IT COVERS THE DISTAL END OF CATHETER. INTRODUCE THE GUIDEWIRE AND MICRO CATHETER AS A UNIT THROUGH THE HEMOSTATIC PORT OF THE HEMOSTATIC SIDEARM ADAPTER INTO THE LUMEN OF THE GUIDING CATHETER. ADVANCE GUIDEWIRE/CATHETER ASSEMBLY TO THE DISTAL TIP OF THE GUIDING CATHETER.¿ 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

    THE ECHELON CATHETER WAS NOT RETURNED FOR ANALYSIS; THEREFORE, NO DEFINITIVE CONCLUSION CAN BE DRAWN REGARDING THE CLINICAL OBSERVATION. HOWEVER, THE DEVICE IS PENDING RETURN. UPON RECEIPT OF THE DEVICE AND/OR ADDITIONAL INFORMATION A SUPPLEMENTAL REPORT WILL BE FILED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THAT DURING THE PREPARATION, THE ECHELON MARK BAND WAS REPORTED TO HAVE BEING DAMAGED AND DISLODGED. THE CATHETER WAS SHAPED PER THE INSTRUCTIONS FOR USE (IFU). NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924970 ECHELON CATHETER, CONTINUOUS FLUSH KRA COVIDIEN (IRVINE) 190-5091-150 A662302

    Patients

    Seq Age Sex Outcome Treatment
    1