BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHENOM CATHETER

    MDR report key: 24941472 · Received April 21, 2026

    Report

    Report Number
    9617601-2026-02581
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    April 14, 2026
    Report Date
    May 6, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    QJP
    UDI-DI
    00763000304317
    PMA / PMN Number
    K151638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: PED2-450-20 (D031985). 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

    IT WAS REPORTED THAT AN UNRUPTURED SACCULAR ANEURYSM OF THE LEFT PARAOPHTHALMIC INTERNAL CAROTID ARTERY WAS TREATED WITH FLOW DIVERSION USING A PIPELINE EMBOLIZATION DEVICE PLUS COILS, AND DUAL ANTIPLATELET THERAPY WAS ADMINISTERED. THE ANEURYSM MAXIMUM DIAMETER WAS 5.8 MM WITH A NECK DIAMETER OF 55.8 MM, DISTAL LANDING ZONE ARTERY SIZE WAS 3.6 MM AND PROXIMAL LANDING ZONE ARTERY SIZE WAS 4.3 MM, VESSEL TORTUOSITY WAS MINIMAL, AND ACCESS WAS VIA THE LEFT INTERNAL CAROTID ARTERY WITH AN ACCESS VESSEL DIAMETER OF 4.3 MM. AFTER SUCCESSFUL PIPELINE DEPLOYMENT, PTFE SLEEVES COULD NOT BE RECAPTURED BY THE PHENOM 27 MICROCATHETER. AFTER REMOVAL OF THE SLEEVES OUTSIDE, THE CATHETER WAS OBSERVED TO BE "RIBBLED". THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS REPORTED AS GOOD. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN INFINITY SHEATH AND AXIUM COILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323627 PHENOM CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDTRONIC MEXICO S. DE R.L. DE CV FG15150-0615-1S 229716723 00763000304317

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male SEE H11.