BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHENOM CATHETER

    MDR report key: 25057261 · Received May 1, 2026

    Report

    Report Number
    9617601-2026-02857
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 13, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    QJP
    UDI-DI
    00763000276171
    PMA / PMN Number
    K151638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION ADDED TO EVENT SUMMARY. 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 PED3-021-350-20 (B626023); PRODUCT TYPE: IMPLANT DATE N/A; EXPLANT DATE N/A. 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. NO CAUSE WAS OBSERVED THAT COULD AFFECT THE EFFECTIVENESS OF THE DEVICE.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 9 MM AND A 4MM NECK DIAMETER. THE LANDING ZONE WAS 3.2MM DISTALLY AND 3.5MM PROXIMALLY. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS RIGHT RADIAL, WITH 4MM DIAMETER. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS REPORTED AS THE PATIENT BEING ON CLOPIDOGREL AND ASPIRIN (ASA). IT WAS REPORTED THAT THE PHENOM 21 MICROCATHETER IS PLACED ON THE WORKTABLE. THE CARRIER SHEATH IS PRIMED WITH HEPARINIZED SALINE SOLUTION, AND INTERNAL PRIMING IS PERFORMED WITH HEPARINIZED SALINE SOLUTION. THE DISTAL PART OF THE INTRODUCER SHEATH WAS INSERTED INTO THE MICROCATHETER VALVE UNTIL FLUID EXITED FROM THE DISTAL END OF THE INTRODUCER SHEATH, AND ADVANCEMENT INTO THE MICROCATHETER (PREVIOUSLY CONNECTED TO THE PHENOM) WAS THEN INITIATED. THE MICROCATHETER WAS FLUSHED WITH A SYRINGE BEFORE REMOVAL FROM THE SHEATH AND WITHIN ITS INTERNAL LUMEN USING HEPARINIZED SALINE. IT WAS THEN CONNECTED TO HEPARINIZED IRRIGATION, FLUSHED AGAIN, AND THE PREVIOUSLY FLUSHED MICRO GUIDEWIRE WAS ADVANCED. THE HEMOSTATIC VALVE IS ASSEMBLED WITH IRRIGATION CONNECTED, PREVIOUSLY PREPARED WITH THE INDICATED MEDICATIONS. A 0.014 MICRO GUIDELINE IS THEN ADVANCED WITH IRRIGATION OPEN. A PED PIPELINE VANTAGE FLOW DIVERTER IS T HEN INSERTED INTO THE HEMOSTATIC VALVE, WITH THE DISTAL PORTION OF THE CARRIER SHEATH INSERTED. THE ENTIRE SHEATH IS PRIMED UNTIL SALINE SOLUTION FLOWS FROM THE PROXIMAL PORTION OF THE SHEATH. THE SPECIALIST PLACES THE DISTAL PORTION OF THE SHEATH ONTO THE PROXIMAL PORTION OF THE MICROCATHETER (HOP-TO-HOP). THE DIVERTER IS THEN TRANSFERRED TO THE MICROCATHETER WITHOUT RESISTANCE. THE DEVICE IS ADVANCED THROUGH THE MICROCATHETER UNTIL INCREASED RESISTANCE IS FELT AGAINST THE WALLS OF THE MICROCATHETER. TENSION-RELIEVING MANEUVERS ARE PERFORMED, BUT THE DEVICE CONTINUES TO ENCOUNTER RESISTANCE AND BECAME STUCK IN THE DISTAL SECTION OF THE CATHETER DURING DELIVERY. DURING THIS ADVANCEMENT, THE PUSHWIRE WAS BEND IN THE PROXIMAL SECTION DUE TO DIFFICULTY ADVANCING THE DEVICE WITHIN THE MICROCATHETER, AND FURTHER ADVANCEMENT IS OBSERVED. THE DIVERTER WAS INSERTED INTO THE ARTERY, BUT IT DID NOT RETRACT. THE PHYSICIAN ATTEMPTED TO RELEASE THE LOAD (SLACK) IN THE SYSTEM TO RESOLVE THE ISSUE; HOWEVER, THIS DID NOT RESOLVE THE PROBLEM. THE CATHETER WAS NOT DAMAGED. THE DOCTOR DECIDED TO REMOVE EVERYTHING AND INSERT NEW DEVICES, WHICH WERE INSERTED WITHOUT COMPLICATIONS. THE ANGIOGRAPHIC RESULT POST-PROCEDURE SHOWED NO COMPLICATIONS. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION, THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION, AND NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A RIST GUIDE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82147 PHENOM CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDTRONIC MEXICO S. DE R.L. DE CV FG13160-0615-1S 232528864 00763000276171

    Patients

    Seq Age Sex Outcome Treatment
    1