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

Model Number	RFX058-115-08
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an aneurysm surgery, a dsc 5f x 115cm us catheter was used via the femoral artery, which had a diameter of 6.1 mm and minimal vessel tortuosity.After the catheter entered the body, the tip was found to be broken during the procedure.The devices were prepared according to the instructions for use (ifu).The catheter was flushed as per ifu.The catheter was replaced with a new one and the surgery was continued.No patient complications have been reported as a result of 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 was received stating that the cause of the catheter tip broken was not determined.
Additional Manufacturer Narrative
Product analysis ¿ as found condition: the navien catheter was returned within a shipping sleeve and a plastic bio-pouch.¿ visual inspection/damage location details: no damage was found with the navien catheter hub.The navien catheter body was found broken at ~82.8cm from the proximal end of the catheter hub.The navien catheter distal tip was found to be in good condition.¿ testing/analysis: the navien catheter total length was measured to be ~123.1cm and the usable length was measured to be ~116.5cm, which is within specification.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿catheter separation/break¿ report was confirmed as the navien catheter was found to be broken.Catheter separation/break can be caused by advancing/retrieving intraluminal devices against resistance, vasospasm, patient vessel tortuosity, entrapment in vessels, or excessive force.In the event description, entrapment in the vessel, excessive force during advancement or retrieval, and vasospasm were not reported, which effectively rules out these potential causes.Additionally, the patient¿s vessel tortuosity was minimal, further eliminating it as a contributing factor.¿ the catheter was prepared and flushed as indicated in the instructions for use (ifu) prior to use; therefore, it is likely that the separation occurred after preparation and during the use.However, the root cause cannot be determined.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: 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: 22939549
• Report Number: 2029214-2025-01943
• Device Sequence Number: 10107292
• Product Code: DQY
• UDI-Device Identifier: 00847536017795
• UDI-Public: (01)00847536017795(17)261028(10)B810511
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/03/2025

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: RFX058-115-08
• Device Catalogue Number: RFX058-115-08
• Device Lot Number: B810511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2025
• Supplement Date Received by Manufacturer: 09/03/2025; 10/09/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/30/2025; 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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: Male