MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA RIST; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Model Number	106F-071-95
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #(b)(4): equipment used: vis (m-85519), 203cm ruler (m-83360) as found condition: the rist 071 catheter was returned within a shipping box and a plastic bio-pouch.Visual inspection/damage location details: no damage was found with the rist 071 catheter hub.The rist 071 catheter body was found separated/broken at the strain relief, 4.0cm from the proximal end of the catheter hub, retained by the inner wire.The rist 071 catheter body was found kinked at 14.5cm from the catheter distal tip.The rist 071 catheter distal marker/tip was found to be in good condition.Testing/analysis: none conclusion: based on the device analysis and reported information, the customer¿s ¿catheter separation/break¿ report was confirmed.As the rist 071 catheter body was found separated/broken at the strain relief.The catheter can become damaged if force is used during loading of the non-medtronic catheter into the rist or due to manipulation (e.G., excessive bending, twisting, or pushing).However, the cause could not 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.
Event or Problem Description
It was reported that during a procedure involving a rist catheter, it was noticed the hub was breaking when the technical was about to load the non-medtronic catheter back into the rist.There were no patient symptoms or complications associated with the event, and the patient outcome was reported as alive with no injury.Additional information received reported the breaking was completely at the hub where there was separation.The physician just tried to used the catheter it just broke.

• Brand Name: RIST
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine,ca
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine,ca
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 23342270
• Report Number: 2029214-2025-02242
• Device Sequence Number: 9460982
• Product Code: QJP
• UDI-Device Identifier: 00763000541194
• UDI-Public: (01)00763000541194(17)271105(10)25821-01
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K211990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/20/2025

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: 106F-071-95
• Device Catalogue Number: 106F-071-95
• Device Lot Number: 25821-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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