BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON

    MDR report key: 11542963 · Received March 22, 2021

    Report

    Report Number
    2029214-2021-00316
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    March 17, 2021
    Report Date
    June 25, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    UDI-DI
    00847536005969
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS OF THE ECHELON 10 MICROCATHETER (LOT NO. B033740) FOUND THAT THE CATHETER TIP AND MARKER BAND APPEARED TO BE FLATTENED. THE CATHETER BODY APPEARED TO BE KINKED AT 51.0 CM, 77.0 CM AND 96.0 CM FROM THE DISTAL TIP. NO SEPARATION OR PUNCTURED HOLE WAS FOUND ON RETURNED CATHETER. THE CATHETER TOTAL AND USABLE LENGTHS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE CATHETER WAS FLUSHED WITH WATER AND FOUND TO BE PATENT. THE CATHETER COULD NOT BE USED FOR RESISTANCE TESTING DUE TO ITS DAMAGED CONDITIONS. THE GUIDEWIRE SIZE AND MODEL WERE NOT REPORTED; THEREFORE, ITS COMPATIBILITY FOR USE WITH THE CATHETER COULD NOT BE DETERMINED. BASED ON THE RETURNED DEVICE, THE ECHELON 10 CATHETER WAS NOT CONFIRMED TO HAVE ¿CATHETER SEPARATION¿ AS THE RETURNED CATHETER WAS FOUND TO BE INTACT. THE CATHETER TIP AND MARKER BAND WERE FOUND TO BE FLATTENED. IN ADDITION, THE CATHETER BODY WAS ALSO FOUND TO BE KINKED AT SEVERAL LOCATIONS. IT IS LIKELY THAT THESE DAMAGES OCCURRED WHEN THE CUSTOMER ATTEMPTED TO ADVANCE THE GUIDEWIRE THROUGH THE CATHETER AGAINST THE REPORTED RESISTANCE. POSSIBLE CAUSES OF RESISTANCE INCLUDE VESSEL TORTUOSITY AND LACK OF CONTINUOUS FLUSH DURING DELIVERY. THERE WAS NO CONFORMANCE TO SPECIFICATIONS IDENTIFIED THAT LED TO THE REPORTED ISSUES. SINCE THE GUIDEWIRE WAS NOT RETURNED; ANY CONTRIBUTION OF THE GUIDEWIRE TO THE REPORTED ISSUES COULD NOT BE DETERMINED. H6: METHOD CODE UPDATED TO B01. RESULT CODE UPDATED TO C070601. CONCLUSION CODE UPDATED TO D15. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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 · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THE TIP OF THE MICROCATHETER WAS NOT SEPARATED, THE MICROCATHETER ENTERED THE ANEURYSM DURING THE OPERATION, AND THE MICRO-GUIDEWIRE CAME OUT OF THE SIDE OF THE MICROCATHETER. THE CATHETER WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY.

    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 THE TIPS OF THREE ECHELON CATHETERS WERE CRACKED, BROKEN, AND SEPARATED. THREE AXIUM COILS EXPERIENCED RESISTANCE WHEN THE COIL ENTERED THE DISTAL SEGMENT OF THE ECHELON MICROCATHETER AND COULD NOT BE PUSHED. A FOURTH AXIUM COILS WAS DRAWN IN THE FRONT SEGMENT. REPLACEMENT PRODUCTS WERE USED TO COMPLETE THE PROCEDURE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE OPHTHALMIC SEGMENT WITH A MAX DIAMETER OF 6 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S BLOOD FLOW AND VESSEL TORTUOSITY WERE NORMAL. REFER TO MANUFACTURER REPORT 2029214-2021-00315 FOR DETAILS PERTAINING TO THE RELATED REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444154 ECHELON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 105-5091-150 B033740 00847536005969

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR