BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHENOM CATHETER

    MDR report key: 24028036 · Received January 9, 2026

    Report

    Report Number
    9617601-2026-00204
    Event Type
    Malfunction
    Date Received
    January 9, 2026
    Date of Event
    January 6, 2026
    Report Date
    March 6, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    QJP
    UDI-DI
    00763000865283
    PMA / PMN Number
    K151638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODES UPDATED TO REFLECT THAT THERE WAS NO ALLEGATION AGAINST THE PHENOM PLUS CATHETER/A0509 CODE REMOVED AS RESISTANCE DID NOT OCCUR WITH THE PHENOM PLUS CATHETER. ADDITIONAL REVIEW OF THE EVENT AND ALL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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

    UPDATE B5 MDR DECISION CORRECTED TO NOT REPORTABLE. THE COMPLAINT FLAG CANNOT BE FLIPPED TO 'NO' AS REGULATORY REPORTS EXIST IN THIS EVENT. NO ADDITIONAL SUPPLEMENTAL REPORTS REQUIRED. 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: NV UNK PIPELINE (UNKNOWN). 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. THE ANEURYSM LOCATED IN THE OPHTHALMIC SEGMENT OF THE INTERNAL CAROTID ARTERY. THE PIPELINE DEVICES INVOLVED WERE PED2-400-20 (LOT: D013498) AND PED2-400-18 (LOT: D049284). THE PROBLEM OCCURRED WHEN THE PIPELINE SYSTEM COULD NOT BE ADVANCED INSIDE THE PHENOM 27 MICROCATHETER, DESPITE ALL INSTRUCTIONS FOR USE BEING FOLLOWED CORRECTLY. THIS ISSUE SPECIFICALLY INVOLVED THE MICROCATHETER, AS THE PIPELINE FLAPS BECAME STUCK AND COULD NOT BE ADVANCED. THERE WERE NO PROBLEMS OR OBSERVED BENDING OR DAMAGE TO THE PHENOM 27, PHENOM PLUS CATHETERS, OR THE PIPELINE DEVICES. THE CAUSE OF THE EVENT WAS NOT DETERMINED. THROUGHOUT THE PROCEDURE, A CONTINUOUS FLUSH OF SALINE SOLUTION WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT THE FINS OF THE PIPELINE DELIVERY SYSTEM, AFTER BEING RELEASED, WERE UNABLE TO ENTER THE MICROCATHETER, MAKING IT IMPOSSIBLE TO USE THE MICROCATHETER, WHICH WAS STUCK IN THE PHENOM 27 MICROCATHETER. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR A CEREBRAL ANEURYSM LOCATED IN THE LEFT INTERNAL CAROTID ARTERY. THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92316 PHENOM CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDTRONIC MEXICO S. DE R.L. DE CV FG19120-1030-1S 231932753 00763000865283

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female SEE H11...