MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SUPPORT GUIDECATHETER; CATHETER, PERCUTANEOUS

Model Number	RFX058-125-08
Medical Device Problem Codes	Material Deformation (2976); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
Type of Reportable Event	Malfunction
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
Iit was reported that a navien guide-catheter (gc) was used in a case of an unruptured cerebral aneurysm of the left ic artery.Due to marked vascular tortuosity, the device was initially advanced to the internal carotid artery, but the gc dislodged, necessitating withdrawal from the body.Upon attempting to use the device again, a kink was observed in the distal shaft portion, so it was not used.The procedure was continued and completed with a navien072.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.
Event or Problem Description
Additional information was received.It was noted that the patient's vessel tortuosity was severe.
Additional Manufacturer Narrative
Update b5.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.The patient ica aneurysm was located c2 segment with 7 mm diameter.The patient is improving following the procedure.There was no vessel injury, complication, or patient impact resulting from the dislodgement.No procedural or post-procedural imaging (e.G., ct, angio) is available.The cause of the dislodgement is possibly due to strong vessel tortuosity, while the cause of the kink was not determined.There were no issues that resulted in the damage found, and no resistance or difficulty was noted during catheter advancement or manipulation.The tip of the catheter was not under stress, but there was some movement of the catheter tip during deployment.

• Brand Name: SUPPORT GUIDECATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 23584196
• Report Number: 2029214-2025-02435
• Device Sequence Number: 21176679
• Product Code: DQY
• UDI-Device Identifier: 00847536017849
• UDI-Public: (01)00847536017849(17)251210(10)B667449
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110055
• 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
• Report Date (Section B): 01/20/2026

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 Expiration Date: 12/10/2025
• Device Model Number: RFX058-125-08
• Device Catalogue Number: RFX058-125-08
• Device Lot Number: B667449
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 11/19/2025; 12/24/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/11/2025; 01/20/2026
• Date Device Manufactured: 12/11/2023
• 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