BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHENOM CATHETER

    MDR report key: 25219412 · Received May 19, 2026

    Report

    Report Number
    9617601-2026-03245
    Event Type
    Malfunction
    Date Received
    May 19, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 19, 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
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID PED3-021-250-16 (D003278); 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

    MEDTRONIC RECEIVED A REPORT THAT RESISTANCE WAS ENCOUNTERED DURING DELIVERY AND RECAPTURING THE PIPELINE INSIDE THE PHENOM CATHETER. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM. THE ACCESSED VESSEL WAS THE FEMORAL A RTERY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT THE PHYSICIAN WAS DELIVERING THE PIPELINE THROUGH THE PHENOM 21, IT WAS NOTICED THERE WAS UNUSUAL STIFFNESS, THE PHYSICIAN CONTINUED THE DEPLOYMENT OF THE PIPE. WHEN RECAPTURING THE PIPELINE, STIFFNESS WAS ALSO NOTICED WHILE RECAPTURING THE WINGS. WHEN THE PHENOM 21 WAS FINALLY REMOVED THEY FLUSHED IT ON THE BACK TABLE AND NOTICED 2 BLUE PIECES. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597482 PHENOM CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDTRONIC MEXICO S. DE R.L. DE CV FG13160-0615-1S 229955087 00763000276171

    Patients

    Seq Age Sex Outcome Treatment
    1