BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHENOM CATHETER

    MDR report key: 23292104 · Received October 15, 2025

    Report

    Report Number
    9617601-2025-01997
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    October 6, 2025
    Report Date
    November 12, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    QJP
    UDI-DI
    00763000274870
    PMA / PMN Number
    K151638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PIPELINE FLEX FLOW DIVERSION STENT MODEL NO.: PED2-425-16; LOT NO.: D051868. 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

    UPDATED B5. 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 WHEN AN ATTEMPT WAS MADE TO DELIVER THE PIPELINE FLEX WITH SHIELD TECHNOLOGY STENT (PED2) INTO THE PHENOM 27 MICROCATHETER, RESISTANCE DIFFERENT THAN USUAL WAS ENCOUNTERED. AFTER PARTIAL ADVANCEMENT, STACKING OCCURRED WITHIN THE PHENOM 27, RESULTING IN A SITUATION WHERE NEITHER FORWARD NOR BACKWARD MOVEMENT COULD BE PERFORMED. BOTH PRODUCTS WERE REPLACED WITH MEDTRONIC PRODUCTS OF THE SAME SIZE BUT DIFFERENT LOT NUMBERS, TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS UNDERGOING TREATMENT FOR C6 ANEURYSM WITH A MAX DIAMETER OF 8 MM AND A 4 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE PIPELINE DEVICE BECAME STUCK AT THE PROXIMAL PORTION OF THE CATHETER. AFTER RETRIEVAL, FRAYING AND BREAKAGE WERE OBSERVED AT THE TIP OF THE PIPELINE DELIVERY WIRE OR STENT, WHICH WERE ATTRIBUTED TO RESISTANCE ENCOUNTERED DURING THE PROCEDURE. NO KINKING OR DEFORMATION WAS OBSERVED IN THE PHENOM CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2358168 PHENOM CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDTRONIC MEXICO S. DE R.L. DE CV FG15150-0615-1S 231070659 00763000274870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown