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

Model Number	REACT-71
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that a react catheter stretched at the distal section.The reported device and accessory devices were prepared as indicated in the instruction for use (ifu).The patient was being treated for a thrombectomy.The patient¿s vessel tortuosity was normal.The access vessel was the left femoral artery (diameter 5.2 mm).The asahi 0.014 micro-guidewire was placed through the stryker micro-catheter to the starting point of the middle cerebral artery m1.The micro guidewire was then withdrawn and react-71 was inserted into the end of the internal carotid artery to extract the thrombus.During the aspiration process of react-71, the tip of the tube could not be pulled (repeatedly pulling, it had always been a state of immobility).Then the tip fell directly from the access.After it fell, the surgeon removed react-71 from the body and found that the distal end of the intermediate catheter had an abnormal shape (stretched).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.
Event or Problem Description
Additional information received reported the suspected casue of the problem was catheter itself.
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 71 catheter was returned for analysis within a shipping box and a plastic bio-pouch.Visual inspection/damage location details: no damage was found with the react 71 catheter hub.The react 71 catheter body was found stretched from ~19.0cm to ~6.0cm from the catheter distal tip.The react 71 catheter distal marker/tip was found damaged.Testing/analysis: none conclusion: based on the device analysis and reported information the customer¿s ¿catheter resistance¿ and ¿difficulty navigation¿ reports could not be confirmed.However, the customer¿s ¿catheter stretch during removal¿ report was confirmed as the react 71 catheter body was found stretched.It is possible that the damage found with the react 71 catheter distal marker/tip contributed to the reported event.However, the cause of the reported event could not be determined.The react 71 catheter distal marker/tip can become damaged due to patient vessel tortuosity, advancing/retrieving against resistance, or vessel calcification or stenosis.The react 71 catheter body can become stretched due to patient vessel tortuosity or advancing/retrieving against resistance.However, the cause of the catheter damage 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: 21865313
• Report Number: 2029214-2025-01017
• Device Sequence Number: 4721242
• Product Code: QJP
• UDI-Device Identifier: 00847536044197
• UDI-Public: (01)00847536044197(17)260304(10)B704104
• 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,Followup
• Report Date (Section B): 07/01/2025

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: 03/04/2026
• Device Model Number: REACT-71
• Device Catalogue Number: REACT-71
• Device Lot Number: B704104
• 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: 04/16/2025
• Supplement Date Received by Manufacturer: 04/21/2025; 06/25/2025
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 05/06/2025; 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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: 55 YR
• Patient Sex: Female