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

Model Number	REACT-71
Medical Device Problem Codes	Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
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
Medtronic received a report that the patient was undergoing treatment for an acute cerebral infarction.It was noted that the patient's vessel tortuosity was severe.The access vessel was left internal carotid artery, with 6mm diameter.I it was reported that during acute stroke treatment, when attempting to guide the product to the left internal carotid artery, strong vascular tortuosity made advancement impossible, so the catheter was withdrawn.At that time, it was confirmed that the marker band at the catheter tip had detached and dislodged.The marker was retrieved.The catheter was removed from the package according to the instructions in the package insert.It is unknown whether any additional surgical or medical procedures were performed.The reported device and any accessory devices were prepared and flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.
Event or Problem Description
Additional information was received that the cause of the marker band dislodgement was not determined.
Additional Manufacturer Narrative
H3 product analysis: ¿ as found condition: the react was returned within a shipping box and a plastic bio-pouch.¿ visual inspection/damage location details: no damage was found to the react catheter hub.The react catheter body was found to be in good condition.The react distal tip was found to be damaged as the marker band was dislodged.¿ testing/analysis: the react catheter total length was measured to be ~140.3cm and the usable length was measured to be ~134.1cm, which is within specification.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿marker band dislodged¿ was confirmed as the returned react market band was dislodged.However, ¿difficulty navigation¿ could not be confirmed.Marker band dislodged can be caused by advancing and retrieving intraluminal device against resistance, highly tortuous patient anatomy, kink/damage in the sheath, guidewire/stents contributing to resistance during delivery and/or withdrawal/re-sheathing, or hard clots/calcifications in the navigation tract which may snag the catheter.Catheter navigation can be caused by incompatible devices, patient vessel tortuosity, damage to guidewire, damaged catheter, or lack of continuous saline flush during delivery.Information regarding if continuous saline flush was maintained or hard clots/calcification where present, was not reported, potentially ruling out these causes.In addition, the make/model of the guidewire/intermediate catheter was not reported.Therefore, an analysis could not be performed, and any contributing factors (including incompatible devices) could not be assessed.In the event, it is also possible that the patient¿s severe tortuosity, catheter damage and advancement/retrieval of an intraluminal device against resistance may have contributed to the reported event.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: 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: 23584108
• Report Number: 2029214-2025-02433
• Device Sequence Number: 15802324
• Product Code: QJP
• UDI-Device Identifier: 00847536044197
• UDI-Public: (01)00847536044197(17)260122(10)B685593
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182097
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2025

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: 01/22/2026
• Device Model Number: REACT-71
• Device Catalogue Number: REACT-71
• Device Lot Number: B685593
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2024
• 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