BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHENOM CATHETER

    MDR report key: 25245079 · Received May 21, 2026

    Report

    Report Number
    9617601-2026-03337
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    May 18, 2026
    Report Date
    May 21, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    QJP
    UDI-DI
    00763000399702
    PMA / PMN Number
    K151638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: PED2-375-18 (D072947). 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 PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED INTRACRANIAL ANEURYSM AT C6 SEGMENT WITH A MAX DIAMETER OF 5MM AND A 4 MM NECK DIAMETER. THE LANDING ZONE WAS 3.9 MM DISTALLY AND 3.7 MM PROXIMALLY. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY, WITH AN UNKNOWN DIAMETER. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS UNKNOWN. IT WAS REPORTED THAT AFTER THE PED2 STENT DELIVERY THE MICROCATHETER WAS POSITIONED, AND THE STENT WAS ADVANCED; HOWEVER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED AT THE PROXIMAL SECTION, AND IT COULD NOT BE DELIVERED. THE OPERATOR PLANNED TO WITHDRAW THE STENT, BUT IT BECAME STUCK WITHIN THE MICROCATHETER. THE STENT AND MICROCATHETER WERE THEREFORE WITHDRAWN TOGETHER, AND THE PROCEDURE WAS COMPLETED AFTER REPLACING THEM WITH A NEW MICROCATHETER AND STENT. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED BLOOD STAGNATION WITHIN THE ANEURYSM. 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 PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A 6F SILVER SNAKE GUIDE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419636 PHENOM CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDTRONIC MEXICO S. DE R.L. DE CV FG15150-0615-1S 232175576 00763000399702

    Patients

    Seq Age Sex Outcome Treatment
    1