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

Model Number	106F-071-105
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
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
It was reported that during a neurovascular procedure involving the catheter radial guide, several issues were observed.The hub broke off from the catheter where the white hub ends on the back table.Additionally, the device had a kink on the proximal end near the hub, and blood was noticed coming from the distal end of the device.The device was also cracked on the proximal end near the hub.Despite these issues, the procedure was completed safely without injury to the patient, and the catheter was removed as soon as possible.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.
Event or Problem Description
Additional information received reported that the physician placed an exchange wire in the patient and switched out the catheter with another rist catheter to resolve the catheter/hub break.The device had a crack on the proximal end so blood was leaking out of the side of the catheter.The actual cause was not determined.Two other rist catheters that were broken or kinked getting pulled out of the package were also noted.It was most likely the cause of the break in the catheter.
Additional Manufacturer Narrative
H3: product analysis ¿ as found condition: the rist 071 catheter was returned for analysis within a shipping box and a plastic bio-pouch.¿ damage location details: no damage was found with the rist 071 catheter hub.The rist 071 catheter body was found flattened from ~4.5cm to ~5.0cm from the proximal end of the catheter hub.The rist 071 catheter body was found kinked at ~22.5cm from the proximal end of the catheter hub.The rist 071 catheter distal marker/tip was found damaged (ovalized).¿ testing/analysis: none ¿ conclusion: based on the device analysis and reported information, the customer¿s ¿hub cracked¿ and ¿catheter separation/break¿ reports could not be confirmed.However, the customer¿s ¿catheter kink/damage¿ report was confirmed.Possible causes of ¿catheter kink/damage¿ include patient vessel tortuosity, advancing or retrieving the device against resistance, or entrapment in the vessel.In addition, catheter damage can occur during packaging or while removing the catheter from the packaging.However, the root 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.

• 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: 21753801
• Report Number: 2029214-2025-00858
• Device Sequence Number: 8200065
• Product Code: DQY
• UDI-Device Identifier: 00763000541217
• UDI-Public: 00763000541217
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/02/2025

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-071-105
• Device Catalogue Number: 106F-071-105
• Device Lot Number: 25452-01
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 04/03/2025; 05/07/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 04/29/2025; 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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 Age: 87 YR
• Patient Sex: Female