BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON

    MDR report key: 25331606 · Received May 29, 2026

    Report

    Report Number
    9612501-2026-01485
    Event Type
    Malfunction
    Date Received
    May 29, 2026
    Date of Event
    March 5, 2026
    Report Date
    May 29, 2026
    Manufacturer
    MEDTRONIC DOMINICANA
    Product Code
    KRA
    UDI-DI
    00763000412364
    PMA / PMN Number
    K093750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS AS FOUND CONDITION (CONDITION OF RETURNED DEVICE): AN ECHELON-10 MICRO CATHETER WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX; WITHIN A SEALED BIOHAZARD POUCH AND WITHIN ITS OPENED INNER POUCH. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: UPON VISUAL EXAMINATION, NO ISSUES WERE FOUND WITH THE ECHELON-10 HUB OR ECHELON-10 CATHETER BODY. THE DISTAL MARKER BAND AND DISTAL TIP WERE FOUND TO BE SEPARATED AND NOT RETURNED. THE TUBING MATERIAL OF THE CATHETER SEPARATED END EXHIBITED STRETCHING WITH JAGGED EDGES. THE DISTAL TIP WAS NOTED TO BE PRE-SHAPED. NO OTHER ANOMALIES WERE OBSERVED. TESTING/ANALYSIS (INCLUDING SEM REPORTS): THE ECHELON-10 TOTAL LENGTH WAS MEASURED TO BE ~155.4CM. THE ECHELON-10 USEABLE LENGTH WAS MEASURED TO BE ~147.7CM. CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿PROD DAMAGED/DEFORMED OUT OF PKG¿ WAS UNABLE TO BE CONFIRMED AS THE DISTAL TIP WAS NOT RETURNED. HOWEVER, THE BROKEN END OF THE CATHETER EXHIBITED PLASTIC DEFORMATION (STRETCHING AND JAGGED EDGES) WHICH INDICATE THAT THE CATHETER SEPARATED WHEN EXCEEDING THE TENSILE STRENGTH OF THE TUBING MATERIAL. IT IS POSSIBLE THE ECHELON-10 MICRO CATHETER BECAME DAMAGED UPON REMOVAL FROM THE PACKAGING. PER THE ECHELON IFU (INSTRUCTIONS FOR USE): ¿MODEL NUMBERS 145-5091-150, 145-5092-150, 190-5091-150, AND 190-5092-150 ARE PROVIDED IN A TRAY WITH LID, AND THE CATHETER TIP IS HELD WITHIN THE GROOVE OF A CURVE RETAINER. TO OPEN THE TRAY, LIFT THE LID AT THE CORNER OF THE TRAY WITH THE CATHETER HUB. THE CATHETER AND CURVE RETAINER MAY BE REMOVED FROM THE TRAY TOGETHER. TO FREE THE CATHETER TIP FROM THE CURVE RETAINER, PINCH TWO OPPOSITE CORNERS BACK. THIS OPENS THE GROOVE. LIFT THE CATHETER TIP OUT OF THE GROOVE. INSPECT THE CATHETER PRIOR TO USE TO VERIFY THAT IT IS UNDAMAGED.¿ THE ROOT CAUSE COULD NOT BE DETERMINED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿CATHETER STRETCHED/FLATTENED¿ WAS UNABLE TO BE CONFIRMED AS THE DISTAL TIP WAS NOT RETURNED. THE ROOT CAUSE COULD NOT BE DETERMINED. 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

    MEDTRONIC RECEIVED A REPORT THAT THE ECHELON 10 MICROCATHETER WAS FLATTENED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANEURYSM. THE ACCESS VESSEL WAS THE FEMORAL ARTERY WITH A DIAMETER OF 4 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT DURING THE SURGERY, AFTER THE MICROCATHETER WAS REMOVED FROM THE DEVICE TRAY, IT WAS DISCOVERED THAT THE MICROCATHETER WAS FLATTENED WHEN THE SHAPING NEEDLE WAS PREPARING TO SHAPE IT. FOR THE SAFETY OF THE SURGERY AND THE PATIENT, IT WAS DECIDED TO REPLACE IT WITH A MICROCATHETER OF THE SAME MODEL, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THERE WERE NO CAUSES OR CONTRIBUTING FACTORS FOR THE EVENT IDENTIFIED. THE LESION CHARACTERISTICS PROVIDED, "ANEURYSM IN THE LEFT OPHTHALMIC ARTERY SEGMENT, 3.7*4.2MM." THERE WAS NO DAMAGE NOTICED UPON OPENING THE PACKAGE. NO PREP WAS PREFORMED PRIOR TO THE DAMAGE BEING SEEN. NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406669 ECHELON CATHETER, CONTINUOUS FLUSH KRA MEDTRONIC DOMINICANA 145-5091-150 0232132904 00763000412364

    Patients

    Seq Age Sex Outcome Treatment
    1