BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARKSMAN

    MDR report key: 23283986 · Received October 15, 2025

    Report

    Report Number
    9617601-2025-01971
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    October 11, 2025
    Report Date
    November 12, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    KRA
    UDI-DI
    00847536026261
    PMA / PMN Number
    K091559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED B5. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: PED-250-16 (D041983). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE FAILURE TO RETRIEVE WAS NOT DETERMINED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT THE CATHETER WAS SUCCESSFULLY GUIDED TO THE DISTAL END OF THE ANEURYSM. AFTER DEPLOYMENT OF THE PED-250-16 STENT, THE DENSE MESH STENT PUSHER ROD COULD NOT BE RETRIEVED INTO THE CATHETER. THE CATHETER AND THE STENT PUSHER ROD WERE THEN REMOVED TOGETHER FROM THE BODY, BUT IT STILL COULD NOT BE RETRIEVED INTO THE CATHETER. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THE PIPELINE WAS USED FOR AN APPROVED (ON-LABEL) INDICATION. THE PATIENT IS ALIVE WITH NO INJURY. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT WAS UNDERGOING PED IMPLANTATION FOR ANEURYSM SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED RIGHT MIDDLE CEREBRAL ARTERY ANEURYSM WITH A MAX DIAMETER OF 4 MM AND A 3 MM NECK DIAMETER. THE DISTAL LANDING ZONE WAS, THE PROXIMAL LANDING ZONE WAS 2.3MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 5MM. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS BLOOD VESSEL PATENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183957 MARKSMAN CATHETER, CONTINUOUS FLUSH KRA MEDTRONIC MEXICO S. DE R.L. DE CV FA-55150-1030 229431694 00847536026261

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male SEE H11.