BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHENOM CATHETER

    MDR report key: 23924705 · Received December 30, 2025

    Report

    Report Number
    9617601-2025-03797
    Event Type
    Malfunction
    Date Received
    December 30, 2025
    Date of Event
    December 22, 2025
    Report Date
    January 13, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    QJP
    UDI-DI
    00763000304348
    PMA / PMN Number
    K151638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 UPDATED WITH ADDITIONAL INFORMATION RECEIVED. H6: DEVICE CODE UPDATED BASED ON AVAILABLE INFORMATION. THIS DEVICE IS NO LONGER REPORTABLE AND IS NOT CONSIDERED A COMPLAINT AS THERE WAS NO DEVICE MALFUNCTION/DEFICIENCY AND NO PATIENT COMPLICATION OR INJURY ASSOCIATED WITH THIS EVENT. NO ADDITIONAL SUPPLEMENTAL MDRS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED MAKES THIS DEVICES REPORTABLE. 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 PED3-021-350-20 (D050452); PRODUCT ID PED3-021-350-16 (D050415); PRODUCT ID FG13150-0615-2S (229938289). 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THE RESHEATHING ISSUE OCCURRED ONLY WITH THE FIRST PIPELINE (PED3-021-350-20. LOT:D050452) AND THE PHENOM 21 MICRO CATHETER (FG13150-0615-2S, LOT: 229938289). RESISTANCE OCCURRED WITH THE PIPELINE IN THE DISTAL END OF THE PHENOM 21 MICROCATHETER. IT WAS NOTED THAT CONTINUOUS FLUSH WAS ADMINISTERED AND MAINTAINED DURING THE PROCEDURE AS INDICATED IN THE IFU. THERE WAS NO DAMAGE OBSERVED TO THE PIPELINE PUSHWIRE, NOR TO THE PHENOM21 OR PHENOM PLUS CATHETERS. THE SECOND PIPELINE WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS NO ISSUE REPORTED INVOLVING THE PHENOM PLUS CATHETER (FG19120-1030-1S, LOT: 231481250) OR THE SECOND/IMPLANTED PIPELINE (PED3-021-350-16, LOT: D050415). PLI20 AND PLI40 ARE NO LONGER REPORTABLE AND ARE NOT CONSIDERED COMPLAINTS. MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL MDRS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED MAKES THESE PLI'S/DEVICES REPORTABLE. DUE TO GCH FUNCTIONALITY, THE COMPLAINT FLAG ON THESE PLIS CANNOT BE FLIPPED TO 'NO' AS A REGULATORY REPORT EXISTS IN THIS PE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE DEPLOYMENT OF THE PIPELINE VANTAGE WITH SHIELD TECHNOLOGY FLOW DIVERTER DEVICE FOR THE TREATMENT OF AN UNRUPTURED, FUSIFORM CAROTID TIP ANEURYSM (MAXIMUM DIAMETER 5 MM, NECK DIAMETER 4 MM), IT WAS NOT POSSIBLE TO RESHEATH THE DEVICE DURING THE PROCEDURE, DESPITE NO VISUAL EVIDENCE OF TWISTING. MULTIPLE DEVICES WERE INVOLVED. ATTEMPTS TO RESHEATH THE DEVICE OUTSIDE THE SYSTEM WERE ALSO UNSUCCESSFUL, AND UPON OPENING, INCREASED RADIOPACITY WAS OBSERVED AT THE ZONE INVOLVED IN THE UNSUCCESSFUL RESHEATHING PROCESS. THE PROCEDURE WAS PERFORMED USING TRIAXIAL ACCESS VIA THE FEMORAL ARTERY (DIAMETER 8 MM) WITH NORMAL VESSEL TORTUOSITY, AND DUAL ANTIPLATELET THERAPY (ASA AND PLAVIX) WAS ADMINISTERED. GUIDE CATHETER (INFINITY PLUS) AND GUIDEWIRE (SYNCRO) WERE USED, AND ALL DEVICES AND ACCESSORIES WERE PREPARED AND FLUSHED AS INDICATED IN THE INSTRUCTIONS FOR USE. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS REPORTED AS GOOD. NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE LANDING ZONE WAS 3.3 MM DISTAL AND 3.5 MM PROXIMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2260185 PHENOM CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDTRONIC MEXICO S. DE R.L. DE CV FG19120-1030-1S 231481250 00763000304348

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male SEE H11...