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); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a react catheter was kinked in the proximal section.The patient was undergoing surgery for treatment of an ischemic stroke.It was noted the patient's vessel tortuosity was normal.The access vessel was the right femoral artery.It was reported that during the left middle cerebral artery thrombectomy, when the distal access catheter was unsealed, it was found that the tail end of the catheter was broken, and the catheter was replaced and the operation was completed.The reported device and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.Additional information was received that the damage was noticed when opening the package and no further preparation was taken.It was clarified that the catheter was just kinked.The cause of the damage was not determined.There was no damage or evidence of tampering to device packaging.
Additional Manufacturer Narrative
H3: the react 68 catheter was returned for analysis.No damage was found with the react 68 catheter hub.The react 68 catheter body was found kinked at the strain relief ~6.5cm from the proximal end of the catheter hub.The distal end of the react 68 catheter was found separated, likely cut.When compared to the product drawing, ~1.8cm to ~4.8cm of the distal end of the react 68 catheter was found separated and not returned.The react 68 catheter total length was measured to be ~136.7cm and the useable length was measured to be ~130.2cm.Based on the device analysis and reported information, the customer¿s ¿catheter kink/damage¿ report was confirmed.The returned react 68 catheter was found kinked and separated.Damage can occur due to an impact from an unknown source prior to being opened, damage during storage, use-related, or manufacturing-related (e.G., operator handling damage, missed inspection).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.

• 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: 22303492
• Report Number: 2029214-2025-01441
• Device Sequence Number: 8017095
• Product Code: QJP
• UDI-Device Identifier: 00847536041967
• UDI-Public: 00847536041967
• 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
• Report Date (Section B): 06/21/2025

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: 09/13/2025
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: B627845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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 Sex: Male