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

Model Number	REACT-68
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a react catheter kinked.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for a thrombectomy for cerebral infarction.The patient¿s vessel tortuosity was normal.The access vessel was the femoral artery (diameter 9 mm).The patient was on the operating table due to acute cerebral infarction.Angiography revealed severe tortuosity of the left internal carotid artery and thrombosis of the ipsilateral middle cerebral artery m1.After the micro-guidewire and microcatheter arrived at the location, they were prepared to aspirate in place.When the react catheter was pushed upper, repeated attempts were made, but the catheter was difficult to reach the lesion.After the catheter was removed, it was found kinked.To ensure the safety of the operation, it was replaced with another one, and the thrombus was successfully removed, and the surgery was completed.The catheter was flushed as indicated in the ifu.There were no patient symptoms or complications associated with 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.
Additional Manufacturer Narrative
Product analysis: as found condition: the react 68 catheter was returned for analysis inside a biohazard bag and a shipping box.There was no device packaging returned with catheter.Damage location details: the catheter tip and marker were examined; no damages were found.The catheter body was found to be kinked at 22.5cm and 53.5cm from the distal tip, and at 22.0cm from the proximal end of the catheter hub.No flash or voids molded were observed in the hub.No other anomalies were observed.Testing/analysis: the total and usable lengths of the catheter were measured to be within specifications.The catheter was flushed and found to be patent.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: 21918367
• Report Number: 2029214-2025-01078
• Device Sequence Number: 8907579
• Product Code: QJP
• UDI-Device Identifier: 00847536041967
• UDI-Public: (01)00847536041967(17)250803(10)B605890
• 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
• Report Date (Section B): 07/02/2025

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 Expiration Date: 08/03/2025
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: B605890
• 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: 04/25/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 76 KG