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

Model Number	REACT-71
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the react catheter was found kinked/broken during use.The patient was undergoing surgery for treatment of an acute great vessel occlusion.The accessed vessel was the right femoral artery with a diameter of 7 mm.It was noted the patient's vessel tortuosity was moderate.It was reported that before the operation started, the product was inspected and the react71 was unsealed.No problems were found.During the operation, the react71 was pushed up to the c7 segment, and the thrombus was closely contacted for suction.It was found that there was no pressure in the suction.After taking out the react71, it was inspected in vitro.It was found that the catheter wall was kinked and broken, so a new product was replaced to continue the operation.It was reported a catheter leak occurred in the distal section that was observed during use.The catheter was inspected or tested prior to use.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.Additional information received reported there was no breakage of the catheter.When the catheter was in place, negative pressure suction was performed and it was found that the catheter had no negative pressure.When the catheter was removed, it was found that there was kinking causing air leakage.The reason for the kinking was not determined.
Additional Manufacturer Narrative
The event is conservatively reported at this time based on additional information received which indicated a possibly reportable event.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Product analysis of react-71, lotno:b619111 ¿ as found condition - the react-71 catheter was returned for analysis within a shipping box, a plastic bio-pouch, an opened react-71 inner pouch (b619111), and a dispenser coil.¿ damage location details - the react-71 catheter body was found stretched from ~14.5cm to ~12.0cm from the catheter distal tip.In addition, the react-71 catheter inner wire was found protruding from the catheter diameter at ~7.5cm from the catheter distal tip.¿ testing/analysis - the react-71 catheter's total length was measured to be ~140.4cm, which is within specification (specification: 141 ± 3cm).The react-71 catheter's usable length was measured to be ~133.7cm, which is within specification (specification: 132 +3cm/-0cm).¿ conclusion - based on the device analysis and reported information, the customer's "catheter kink/damage" and ¿catheter leak¿ reports were confirmed as the returned react-71 catheter was found stretched with the catheter's inner wire protruding from the catheter's diameter.The damages found with the catheter likely contributed to the reported lack of pressure in the suction.The moderate tortuosity of the patient's vessel could have contributed to the kinking.The catheter's inner wire can protrude, possibly due to excessive bending or pulling forces.However, the cause of the damages 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
• 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: 19531296
• Report Number: 2029214-2024-01076
• Device Sequence Number: 7501739
• 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): 07/30/2024

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: 08/28/2025
• Device Model Number: REACT-71
• Device Catalogue Number: REACT-71
• Device Lot Number: B619111
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• 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: 65 YR
• Patient Sex: Female
• Patient Weight: 68 KG