BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARATHON

    MDR report key: 13019058 · Received December 16, 2021

    Report

    Report Number
    2029214-2021-01623
    Event Type
    Injury
    Date Received
    December 16, 2021
    Date of Event
    December 13, 2021
    Report Date
    January 7, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    PMA / PMN Number
    K093750
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED. THE ANATOMICAL LOCATION OF THE CATHETER TIP IS DAVF. 15 MINS OF INJECTION TIME, PHYSICIAN PAUSED 30-60 SEC WHEN ONYX REFLUX AND CONTINUE TO INJECTION. INJECTION WAS CONTINUOUS. THERE WAS ONYX REFLUX AT THE DISTAL END OF MARATHON. THE DEAD SPACE WAS FILLED WITH DMSO 0.23 ML. CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE GUIDE CATHETER.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT THE DISTAL END OF THE MARATHON CATHETER SEPARATED AND REMAINED IN THE PATIENT WHEN IT WAS BEING REMOVED AFTER ONYX INJECTION. THE PATIENT WAS UNDERGOING TREATMENT FOR DURAL ARTERIOVENOUS FISTULA (DAVF). THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL DIAMETER WAS <(><<)>2MM. IT WAS NOTED THAT FORCE WAS APPLIED DURING REMOVAL. THERE WAS NO VASOSPASM, AND THE CATHETER WAS NOT STUCK INSIDE THE GUIDE CATHETER. NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. THE PATIENT DID NOT EXPERIENCE ANY INJURY, SYMPTOMS, OR OTHER COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE A MIRAGE GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1914599 MARATHON CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 105-5056 B123490

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female Other