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

Model Number	106F-071-95
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Codes	Vasoconstriction (2126); Foreign Body In Patient (2687)
Date of Event	03/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that a rist catheter separated/broke during use in the proximal section and stretched in the proximal section during removal.The patient was undergoing an embolization procedure.It was noted the patient's vessel tortuosity was minimal.The access vessel was the radial artery.It was reported that the doctor utilized the rist catheter for radial access for a pipeline embolization procedure.The catheter was easily tracked into the left internal carotid artery (ica) where the pipeline was deployed.Upon retraction of the catheter, the catheter unraveled and stretched coming out of the radial artery.The more the catheter was tried to be removed, the more the catheter unraveled.There was surgical intervention required.The catheter fractured in the radial artery and the decision was made to emergently take the patient to the operating room (or) for vascular surgery to remove the remainder of the catheter.Post surgery, some catheter remained inside the patient in the radial artery.There was no friction or difficulty during the injection.There was no force applied during delivery or removal.The catheter tip was not entrapped/stuck.There was vasospasm.The catheter was not stuck ins ide the guide catheter.The reported device and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).
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 the patient is doing well after her procedure.No post images are available.The patient had minimal vasospasm but the healthcare provider (hcp) believes the cause was that the patient has no brachial artery and the radial artery went direct to the axillary artery.
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 the patient received the antispasmodic medication prior to insertion of the rist catheter.

• Brand Name: RIST
• 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: 21765506
• Report Number: 2029214-2025-00873
• Device Sequence Number: 18304756
• Product Code: DQY
• UDI-Device Identifier: 00763000541194
• UDI-Public: 00763000541194
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup,Followup
• Report Date (Section B): 05/19/2025

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: 26146-01
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 04/07/2025; 05/09/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 04/30/2025; 05/19/2025
• Date Device Manufactured: 12/16/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female