MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV PHENOM CATHETER; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Model Number	FG13160-0615-1S
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the patient was undergoing treatment for middle cerebral artery (mca) ischemic cerebral (ic) infarction.It was noted that the patient's vessel tortuosity was moderate.The patient's pre-operative tici score was 1, and the post-operative tici score improved to 2b.The patient was treated with a thrombectomy procedure using a tps (thrombectomy platform system).The solitaire device was used, with zero passes performed during the procedure.The time required from the onset of cerebral infarction to revascularization/revascularize was 30 minutes.It was reported that the phenom 21 and solitaire were selected.The degree of vascular tortuosity leading to the mca was moderate.The optimo 9fr was delivered to the ic, and the phenom 21 was prepared according to the instructions for use (ifu).The chikai 14 wire, which was also prepared according to the ifu, was set up.After delivering the phenom 21 to the occlusion site, an attempt was made to deliver the solitaire stent, which had been prepared according to the ifu, into the phenom 21.However, strong resistance and stiffness were felt.Despite sensing abnormalities in both the phenom 21 and the solitaire, delivery was somehow continued.However, the farther the device was advanced distally, the stronger the resistance became.Ultimately, it became difficult to deliver the solitaire to the distal tip of the phenom 21, and the attempt to deliver the solitaire to the tip of the phenom 21 was abandoned.Since the phenom 21 had crossed the thrombus region, the phenom 21 was left in place, and only the solitaire was retrieved.Subsequently, a newly opened stent retriever from another company was used and successfully delivered into the phenom 21 without any issues.The thrombus was successfully retrieved using the stent from the other company, and the procedure was completed without incident.There were no remnants left in the body.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.
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.
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.
Event or Problem Description
Additional information received reported that there was no health impact to the patient.The cause of the resistance was not determined.There was no damage, but somewhat deformation was confirmed to the stent.There was no kink to the catheter.

• 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 CA 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc CA 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 22486207
• Report Number: 2029214-2025-01577
• Device Sequence Number: 8677659
• Product Code: QJP
• UDI-Device Identifier: 00763000399696
• UDI-Public: (01)00763000399696(17)270929(10)229782803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: FG13160-0615-1S
• Device Catalogue Number: FG13160-0615-1S
• Device Lot Number: 229782803
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/08/2025
• Date Device Manufactured: 09/29/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown