MAUDE Adverse Event Report: Medtronic Mexico S. De R.L. De CV Phenom Catheter; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Model Number	FG15150-0615-1S
Medical Device Problem Codes	Difficult to Advance (2920); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that xinkainuo 6f105 intermediate catheter + xinwei 0.014-200 cm neuro guidewire were used.The phenom27 was advanced under guidance of the neuro guidewire, and an attempt was made to pass through the neck of the giant aneurysm in the posterior communicating segment of the internal carotid artery and advance to the middle cerebral artery.The guidewire passed through the aneurysm neck smoothly, and the phenom27 microcatheter was continued to be advanced.At this time, the tip end of the phenom27 microcatheter herniated into the aneurysm sac, increasing tension, and the microcatheter formed a loop within the aneurysm, making smooth advancement impossible.After multiple adjustments and repeated attempts, the tip end of the phenom27 could not smoothly pass through the aneurysm neck for further advancement.The operator replaced the phenom27 catheter, and after deployment and adjustment, it advanced smoothly into position, completing pipeline implantation.The reported device and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.The patient was undergoing surgery for aneurysm flow-diverting mesh stent implantation.It was noted the patient's vessel tortuosity was moderate.Access vessel was the femoral artery with a 4.03mm diameter.
Additional Manufacturer Narrative
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.

• Brand Name: Phenom Catheter
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• Manufacturer (Section D): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): Medtronic Mexico S. De R.L. De CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; +1(763)526-5677
• MDR Report Key: 50869734
• Report Number: 9617601-2026-05752
• Device Sequence Number: 16131358
• Product Code: QJP
• UDI-Device Identifier: 00763000399702
• UDI-Public: (01)00763000399702(17)280925(10)232325756
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG15150-0615-1S
• Device Catalogue Number: FG15150-0615-1S
• Device Lot Number: 232325756
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 09/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Male