BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARKSMAN

    MDR report key: 10029937 · Received May 6, 2020

    Report

    Report Number
    9612164-2020-01800
    Event Type
    Malfunction
    Date Received
    May 6, 2020
    Date of Event
    April 26, 2020
    Report Date
    May 13, 2020
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    KRA
    UDI-DI
    00836462014077
    PMA / PMN Number
    K091559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6: DEVICE CODE C133513 WAS OMITTED FROM PREVIOUS REPORT IN ERROR. 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 FROM A MANUFACTURING REPRESENTATIVE (REP) INDICATED THERE WERE TWO DIFFERENT MARKSMAN CATHETERS USED IN THE PROCEDURE. THE FIRST STENT WAS STUCK WITH THE MARKSMAN, AND IT COULD NOT BE PUSHED SMOOTHLY. AFTER TAKING IT OUT OF THE BODY, AND TRIED OUT OF BODY, IT STILL COULDN'T BE PUSHED. THEN SECONDLY, THE NEW STENT AND MARKSMAN COULD STILL NOT BE PUSHED, AND THIS MARKSMAN BROKE, AND THE STENT WAS NOT DEPLOYED. AT LAST, IT WAS USED PHENOM27 MICRO-CATHETER TO DEPLOY.

    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 INFORMATION REGARDING A PIPELINE THAT WAS STUCK IN THE MARKSMAN MICROCATHETER. THE PATIENT WAS BEING TREATED FOR AND UNRUPTURED SACCULAR ANEURYSM OF AN OPHTHALMIC ARTERY SEGMENT. THE ANEURYSM MAX DIAMETER WAS 6.88MM AND THE NECK DIAMETER WAS 5.74MM. VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT DURING THE PROCEDURE THE PIPELINE COULD NOT BE PUSHED OUT OF THE MICROCATHETER AND SEEMED STUCK. THE SYSTEM WAS REMOVED FROM THE PATIENT'S BODY AND IT WAS CONFIRMED THAT THE PIPELINE WAS COMPLETELY LOCKED UP IN THE MICROCATHETER. THE CATHETER WAS REPORTED TO BE KINKED AT THE DISTAL END AND THE PUSHWIRE WAS DAMAGED AT THE PROXIMAL END. THE DEVICES WERE REPLACED TO CONTINUE THE PROCEDURE. THE PATIENT DID NOT SUSTAIN ANY HARM OR INJURY. ADDITIONAL INFORMATION RECEIVED FROM THE REP REPORTING THAT THE MARKSMAN CATHETER HAD, IN FACT SEPARATED DURING THE PIPELINE PROCEDURE. THE FIRST SEGMENT WAS REMOVED AND IT WAS NOTED THAT THE DISTAL SEGMENT OF THE CATHETER HAD REMAINED IN PLACE. THE DISTAL END WAS ABLE TO BE CAREFULLY REMOVED AND THE PATIENT DID NOT SUSTAIN ANY HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495037 MARKSMAN CATHETER, CONTINUOUS FLUSH KRA MEDTRONIC MEXICO FA-55150-1030 218057186 00836462014077

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR