BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARATHON

    MDR report key: 8842675 · Received July 30, 2019

    Report

    Report Number
    2029214-2019-00794
    Event Type
    Malfunction
    Date Received
    July 30, 2019
    Date of Event
    July 19, 2019
    Report Date
    October 17, 2019
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DESCRIPTION - ADDITIONAL INFORMATION DEVICE AVAILABLE FOR EVALUATION - ADDITIONAL INFORMATION. DATE MFR REC ¿ ADDITIONAL INFORMATION: TYPE OF FOLLOW UP - DEVICE EVALUATION DEVICE EVALUATED BY MANUFACTURER- ADDITIONAL INFORMATION CODES UPDATED. THE DEVICE WAS RETURNED FOR EVALUATION AND THE CLINICAL OBSERVATION WAS CONFIRMED. AS RECEIVED, THE MARATHON MICRO CATHETER WAS RETURNED FOR ANALYSIS WITHOUT GUIDEWIRE USED IN THE EVENT. THE MARATHON TOTAL LENGTH WAS MEASURED, THE USEABLE LENGTH AND THE DISTAL FLOPPY LENGTH WERE MEASURED AND FOUND WITHIN SPECIFICATION NO DAMAGES WERE FOUND WITH THE MARATHON HUB. NO BENDS OR KINKS WERE FOUND WITH THE MARATHON CATHETER BODY. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE MARATHON DISTAL MARKER/TIP. THE ENTIRE SURFACE OF THE MARATHON CATHETER BODY WAS EXAMINED UNDER MAGNIFICATION. THE MARATHON CATHETER BODY WAS FOUND PUNCTURED AT ~3.3CM FROM THE DISTAL TIP. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, WE WERE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. CATHETER PUNCTURE CAN OCCUR IF THE CATHETER BECOMES KINKED OR PROLAPSED DURING INSERTION OF THE GUIDEWIRE. HOWEVER, THE CAUSE FOR THE PUNCTURE COULD NOT BE DETERMINED. 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 · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. SINCE THE DEVICE WAS NOT RETURNED, WE ARE UNABLE TO PERFORM FURTHER ROOT CAUSE ANALYSIS. ALL DEVICES ARE 100% TESTED AND ALL PRODUCTS ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. NO CORRECTIVE ACTION. MONITORING AND TRENDING THIS TYPE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED REPORT THAT A MARATHON CATHETER WAS PUNCTURE WITH A GUIDEWIRE. THE MARATHON CATHETER DEVICE WAS BEING USED TO TREAT AN ARTERIOVENOUS MALFORMATION (AVM) CASE. THE MARATHON WAS PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS INSIDE THE PATIENT WHEN THE WIRE THEY WERE USING WENT THROUGH THE CATHETER. THE PROVIDER PULLED THE WIRE OUT AS WELL AS THE MARATHON CATHETER. THE PATIENT WAS NOT HARMED. THE PROCEDURE WAS COMPLETED WITH A NEW MARATHON DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637567 MARATHON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1