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

Model Number	REACT-68
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
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 react catheter separated/broke in the distal section during use.The patient was undergoing thrombectomy in the m2 segment of the middle cerebral artery.It was reported that during the process of coaxially inserting the distal access catheter into the proximal segment of the middle cerebral artery thrombus with the micro-guidewire and micro-catheter, the distal access catheter was not shaped, and there was air return when aspirating with a 50ml empty needle, and the negative pressure could not be maintained.The catheter was then removed for inspection and a rupture was found at the catheter's tip.There was force applied during delivery or removal.The catheter tip was not entrapped/stuck.There was no vasospasm.The catheter was not stuck inside the guide catheter.There was no surgical or medicinal intervention required.The catheter was replaced with react-68 for aspiration, and it could remove thrombus and restore blood flow at the first release.The patient's surgery was completed well.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 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 the patient¿s baseline (tici, nihss etc.) was unknown.The patient¿s post-thrombectomy condition (tici, nihss, etc.) the patient returned to normal.Vessel tortuosity was normal.The patient was recovering well from the procedure, all limbs can move.No patient symptoms were reported.The cause of the event was unknown.

• Brand Name: REACT CATHETER
• 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: 19623561
• Report Number: 2029214-2024-01143
• Device Sequence Number: 6359946
• Product Code: DQY
• 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,Followup
• Report Date (Section B): 07/24/2024

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: 02/17/2025
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: B523401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 06/29/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 07/24/2024
• Date Device Manufactured: 02/23/2023
• 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: Unknown