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

Model Number	REACT-68
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
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
Medtronic received a report that the patient came to the operation room due to acute cerebral infarction.Angiography revealed severe tortuosity of the left internal carotid artery and m1 thrombosis in the ipsilateral brain.After the microcatheter and microguidewire were in place, they prepared for aspiration.During the aspiration process, they felt too much resistance.After an unsuccessful attempt, they pulled out the catheter and found that the tip was deformed.Then they replaced the catheter with a new one, and combined aspiration and pulling until the blood vessel was successfully opened and the operation was completed.There was catheter resistance in the distal section.The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of cerebral infarction.It was noted the patient's vessel tortuosity was normal.The access vessel was the femoral artery with a diameter of 8 mm.
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 resistance was and damager were caused by the catheter tip being deformed.
Additional Manufacturer Narrative
Product analysis #: (b)(4): equipment used: vis (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5).Drawing(s) referenced: dwgsreact-68 rev.P.As found condition: the react-68 catheter was returned for evaluation inside a biohazard bag and a shipping box.The rebar 18 catheter was not returned.However, the react-68 appeared to be compatible with the rebar 18 as it has an inner diameter (id) of 0.068".Visual inspection/damage location details: the distal tip and marker band were flattened.The react's body appeared to be kinked at 67.0cm from the distal tip, and at 9.6cm from the proximal end of the catheter hub.No flash or voids molded were observed in the hub.Testing/analysis: the usable length of the react catheter was measured to be within specifications.The react-68 catheter was flushed with water and found to be patent.The catheter was tested by running an in-house 0.050¿ mandrel through the catheter hub.The mandrel successfully passed through the catheter hub with no issues.However, it got stuck at 9.6cm from the proximal end of the catheter hub.Conclusion: based on the analysis findings, the customer complaint was confirmed as the returned react-68 was found to be flattened and kinked.Possible cause includes vessel tortuosity.However, the customer indicated that the vessel tortuosity was normal, which rules it out as a potential cause.The cause of the resistance and damage 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: REACT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• 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: 22002625
• Report Number: 2029214-2025-01163
• Device Sequence Number: 21093106
• Product Code: QJP
• UDI-Device Identifier: 00847536041967
• UDI-Public: (01)00847536041967(17)250518(10)B573178
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K180715
• 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): 07/22/2025

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 Expiration Date: 05/18/2025
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: B573178
• 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: 05/09/2025
• Supplement Date Received by Manufacturer: 05/16/2025; 06/27/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 05/30/2025; 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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 Age: 49 YR
• Patient Sex: Female
• Patient Weight: 67 KG