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

Model Number	FG13150-0615-2S
Medical Device Problem Codes	Retraction Problem (1536); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that a long sheath was placed at right common carotid artery (cca) and a guiding catheter was placed at right internal carotid artery (ica).Deployment of the fd (flow diverter) was attempted but it wasn't opening in the center.Resheathing was performed but it did not open and after that it got stuck in the phenom 21 microcatheter.It was noted there was no alleged product issue with the phenom 21.No patient symptoms or complications were associated with this event.The patient was undergoing flow diversion surgery for treatment of an anterior communicating aneurysm with a target landing zone from the a2 to a1 region.It was noted the patient's vessel tortuosity was severe.Right ica access vessel diameter was 4.3 mm.The reported device and any accessory devices were prepared, and the catheter was flushed, as indicated in the instructions for use (ifu).Ancillary devices included neuronmax sheath, neuron guide catheter, and traxcess guidewire.Additional information received that lesion characteristics (location, size, type, side, dimension, etc.) include: right ica, right a1 approx.2.3 mm, left a2 approx.2.4mm.The cause of the resistance was not determined.There was resistance in the center of the catheter.The flow diverter became stuck in the center of the catheter.The resistance occurred during delivery and during retraction/resheathing in minimal amount.A continuous saline flush was administered and maintained as indicated in the ifu.The flow diversion was a pipeline vantage.There was no damage to the flow diversion pushwire or catheter observed.The procedure was abandoned.
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.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 was received that clipping was done in the next coming day as the pipeline failed to open.
Event or Problem Description
Additional information was received that the aneurysm was treated with clipping.It was noted that are no future plans for medical or surgical interventions for the aneurysm and no medical or surgical interventions required as a cause of the case being abandoned.It was noted that patient was doing well.
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 was received confirming that the patient did have clipping because the pipeline treatment failed even though it was previously reported that there were no future plans for medical or surgical interventions for the aneurysm and no medical or surgical interventions required.
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 ; 7635265677
• MDR Report Key: 23916983
• Report Number: 9617601-2025-03772
• Device Sequence Number: 9147807
• Product Code: QJP
• UDI-Device Identifier: 00763000399689
• UDI-Public: (01)00763000399689(17)280516(10)231360206
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup,Followup,Followup
• Report Date (Section B): 02/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FG13150-0615-2S
• Device Catalogue Number: FG13150-0615-2S
• Device Lot Number: 231360206
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 12/29/2025; 01/13/2026; 01/26/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/08/2026; 01/23/2026; 02/03/2026
• Date Device Manufactured: 05/16/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 60 KG