BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHENOM CATHETER

    MDR report key: 25105392 · Received May 6, 2026

    Report

    Report Number
    9617601-2026-02963
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    May 3, 2026
    Report Date
    May 26, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    QJP
    UDI-DI
    00763000399689
    PMA / PMN Number
    K151638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID PED3-021-350-16 (D050413); 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.

    Additional Manufacturer Narrative · 0

    H3: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. 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 PIPELINE FAILED TO OPEN AND WAS STUCK IN THE PHENOM 21. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, RUPTURED SUPRACLINIOD INTERNAL CAROTID ARTERY (ICA) ANEURYSM WITH A MAX DIAMETER OF 2.2 MM AND A 1.5 MM NECK DIAMETER. THE LANDING ZONE WAS 3.3 MM DISTALLY AND 3.5 MM PROXIMALLY. THE ACCESS VESSEL WAS THE ICA WITH A DIAMETER OF 3.5 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS THAT THE PATIENT IS GOOD NOW. IT WAS REPORTED THAT THE FLOW DIVERTER (FD) WAS OPENED STARTING FROM SUPRACLINOID SEGMENT OF ICA. AFTER UNSHEATHING APPROXIMATELY HALF OF PIPELINE VANTAGE, ADEQUATE OPENING OF DEVICE WAS NOT ACHIEVED. THEREFORE, RESHEATHING WAS ATTEMPTED. THE DISTAL MOST PORTION OF FD COULD NOT BE RESHEATHED FOR PROPER POSITIONING. PUSHING WAS ALSO TRIED HOWEVER ALL ATTEMPTS FAILED. THE PHENOM PLUS WAS PUSHED OVER THE PHENOM 21 IN SUPRACLINIOD ICA. UNSHEATHING WAS ATTEMPTED IN PHENOM PLUS BUT FD WAS STUCK IN PHENOM 21. THERE WAS RESISTANCE IN THE DISTAL SECTION OF THE MICROCATHETER AND THE PIPELINE BECAME STUCK DURING RESHEATHING. THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARANIZED SALINE. THE PHYSICIAN RELEASED THE LOAD (SLACK) IN THE SYSTEM IN AN ATTEMPT TO RESOLVE THE ISSUE; HOWEVER THIS DID NOT RESOLVE THE ISSUE. THE DISTAL SECTION OF THE CATHETER WAS DAMAGED. THERE WAS CRUMPLING OF PHENOM 21 NOTED DUE TO WHICH THE FLOW DIVERTER GOT STUCK IN THE PHENOM 21. THE PUSHWIRE WAS NOT DAMAGED. THE PIPELINE WAS USED FOR AN APPROVED (ON LABEL) INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE AN 8F SHORT SHEATH, PHENOM PLUS GUIDE CATHETER, PHENOM 21 MICROCATHETER, SYNCHRO WIRE (STRYKER) GUIDEWIRE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE CAUSES OR CONTRIBUTING FACTORS FOR THE FAILURE TO OPEN AND RESISTANCE WERE IDENTIFIED AS, "YES, RESISTANCE WAS NOTED IN THE DISTAL SECTION OF THE PHENOM 21 MICROCATHETER. THE DISTAL CATHETER SECTION WAS DAMAGED/CRUMPLED, WHICH CAUSED THE PIPELINE TO BECOME STUCK AND FAIL TO OPEN PROPERLY DURING DEPLOYMENT AND RESHEATHING."A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE DISTAL SECTION OF THE PIPELINE FAILED TO OPEN ADEQUATELY. ADDITIONAL STEPS ATTEMPTED TO OPEN THE PIPELINE WAS RESHEATHING AND SLACK RELEASE. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT, "PLEASE NOTE THAT THE COMPLAINT WAS RAISED DUE TO DIFFICULTY IN OPENING AND RESHEATHING THE PIPELINE VANTAGE DEVICE DURING THE PROCEDURE. THE DEVICE GOT STUCK IN THE PHENOM 21 MICROCATHETER BECAUSE OF CRUMPLING NOTED AT THE DISTAL SECTION OF THE CATHETER DURING RESHEATHING ATTEMPTS. PATIENT OUTCOME WAS GOOD POST PROCEDURE AND NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171687 PHENOM CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDTRONIC MEXICO S. DE R.L. DE CV FG13150-0615-2S 230592042 00763000399689

    Patients

    Seq Age Sex Outcome Treatment
    1