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

Model Number	REACT-71
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
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
It was reported that during a thrombectomy procedure, the react-71 catheter encountered resistance in the middle and was difficult to push through the 8fguide.The procedure involved accessing the femoral artery, which had a diameter of 10 millimeters and minimal vessel tortuosity.The patient's medical history included hypertension for several years.The catheter was prepared and flushed as indicated in the instructions for use (ifu).The catheter was not replaced by a medtronic product but by another manufacturer's product.No patient symptoms or complications were reported.Additional information received that the cause of the resistance was not determined.
Additional Manufacturer Narrative
H3: product analysis ¿ as found condition: the react-71 catheter was returned for analysis within a shipping box, a plastic bio-pouch, and a dispenser coil.¿ damage location details: no damages were found with the react-71 catheter hub.The react-71 catheter body was found kinked at the strain relief ~6.6cm from the proximal end of the catheter hub.The react-71 catheter distal marker/tip was found damaged.¿ conclusion: based on the device analysis and reported information, the customer¿s report could not be confirmed and the cause could not be determined.Possible causes of the resistance include patient vessel tortuosity, incompatible products, damaged catheter(s) (i.E., kinked, bent), flush rate too low, or the external surface of the catheter is not hydrated.The 8f guide catheter was not returned.Therefore, an analysis could not be performed, and any contributing factors could not be assessed.In addition, the make/model was not reported.Therefore, compatibility could not be assessed.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
• 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: 21093526
• Report Number: 2029214-2025-00067
• Device Sequence Number: 21066634
• Product Code: DQY
• UDI-Device Identifier: 00847536044197
• UDI-Public: 00847536044197
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: 07/13/2025
• Device Model Number: REACT-71
• Device Catalogue Number: REACT-71
• Device Lot Number: B597824
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2023
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 56 KG