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

Model Number	REACT-68
Medical Device Problem Codes	Break (1069); Collapse (1099); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
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 middle cerebral artery thrombus was removed.The react-68 catheter tip was found to have a break and was not used.It was replaced with a new react-68 to complete the operation.The distal end was also reported to have been crushed.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.The patient was undergoing surgery for middle cerebral artery embolectomy.It was noted the patient's vessel tortuosity was minimal.The access vessel was the femoral artery with a 6mm diameter.
Event or Problem Description
Additional information received reported the catheter was only broken.Not crushed.The tip was the soft section at the distal end of the catheter.The catheter was broken once the package was opened.
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
H3: product analysis as found condition: the react-68 catheter was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.No other devices used in the event were returned for analysis.Visual inspection/damage location details: no damages or irregularities were found with the react-18 catheter hub.The catheter body was found ruptured at ~1.0cm from the distal end.The distal tip and distal marker band were found ovalized.Testing/analysis: the react-68 total length was measured to be ~140.5cm (specification 141cm ± 3cm), the usable length was measured to be ~133.8cm which is within specification (specification 132cm +3cm/-0cm).The react-68 catheter was flushed, and water was found to exit out the distal tip.The distal end was blocked, and water was found to exit out of the ruptured hole.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter crush¿ and ¿catheter separation/break¿ were confirmed as the distal tip/marker band were found ovalized, and a rupture was observed near the distal end.The rupture found is indicative of over-pressurization.However, the customer reported finding the damage out of packaging and not during preparation/use.Therefore, the likely cause could not be determined.There is an indication that the failure is due to a potential manufacturing issue, therefore, a dhr review will be performed.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: 22296860
• Report Number: 2029214-2025-01432
• Device Sequence Number: 12992299
• Product Code: QJP
• UDI-Device Identifier: 00847536041967
• UDI-Public: (01)00847536041967(17)260819(10)B781226
• 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,Followup
• Report Date (Section B): 08/28/2025

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: 08/19/2026
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: B781226
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 06/23/2025; 08/07/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/21/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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 Age: 46 YR
• Patient Sex: Male
• Patient Weight: 55 KG