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

Model Number	REACT-68
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that after establishing the access and connecting the drip, the surgeon found fluid leakage from the hub proximal to the react68, which affected the normal operation, so he replaced it with another 68 for surgery.There was catheter leak/strain relief.The catheter was not inspected prior to use.The leak was observed during preparation.The device and any accessories were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.
Additional Manufacturer Narrative
Product analysis (b)(4): equipment used: vis (m-78210), 203cm ruler (m-83361) as found condition: the react-68 catheter was returned for analysis within a shipping box, a plastic bio-pouch, an opened react-68 inner pouch (b537642), and a dispenser coil.¿ damage location details: no damages were found with the react-68 catheter hub.The react-68 catheter body was found broken at ~6.7cm from the proximal end of the catheter hub (at the strain relief).The tubing material at the damaged end exhibited with jagged edges.No other damages were found with the react-68 catheter body.The react-68 catheter distal tip was found to be in good condition.Testing/analysis: the react-68 catheter was flushed, water leaked from the broken location.Conclusion: based on the device analysis and reported information, the customer¿s ¿catheter leak¿ report was confirmed as the react-68 catheter leaked from the broken location.As the react-68 catheter was not inspected prior to use, it is possible that damage occurred during preparation.However, the cause of the catheter break 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.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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 19226068
• Report Number: 2029214-2024-00821
• Device Sequence Number: 20743307
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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: 03/20/2025
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: B537642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• 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