MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ECHELON; CATHETER, CONTINUOUS FLUSH

Model Number	105-5091-150
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
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
Medtronic received a report that during an avm surgery, the patient needed to be injected with onyx18.When flushing the microcatheter, water leakage was found at the tip.A new microcatheter was then replaced.The catheter had been inspected or tested prior to use.There were no symptoms.The reported device and any accessory devices were prepared as indicated in the ifu and the catheter was flushed per ifu.Vessel tortuosity was normal.Access vessel was the femoral artery with a diameter of 6.8mm.
Event or Problem Description
Additional information was received that the patient returned to normal after the procedure.It was noted that the catheter didn't enter the body.The catheter was replaced.The cause of the leak was not determined.
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
Product analysis #(b)(4): equipment used: video inspection system (m-85519), ruler (m-83361), camera (panasonic lumix dmc-zs5 as found condition: the echelon-10 micro catheter was returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within a dispenser coil.Visual inspection/damage location details: no damages or irregularities were found with the echelon-10 hub.The echelon-10 catheter body was found kinked at ~44.7cm from the proximal end (figure d).A puncture was found on the micro catheter body at ~1.6cm from the distal end (figures e & f).A second puncture was found at the same length on the other side (figure g).The catheter was found with a cut at ~1.1cm from the distal end (figure h).The catheter was found with coating damage at the same length on the other side (figure i).No damages were found with the echelon-10 distal tip or marker bands.Testing/analysis: the echelon-10 total length was measured to be ~155.9cm and the useable length was measured to be ~148.1cm, which is within specification (specification: total (ref) = 155cm; usable = 147.0 cm ± 1.5cm).The echelon-10 micro catheter was flushed, and water was observed exiting from the distal end as well as the punctured location (figure k).Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter leak¿ was confirmed.The leak was found due to the punctures found on the micro catheter.It is likely an unknown material punctured the device from one side of the catheter (figure g) and exited the other side (figures e & f).The cause of the puncture could not be determined.In addition, the cause of the cut could not be determined.It is possible the damages occurred during production or upon opening the package and attempting to remove the product or after removing it from the package.There is an indication that the event could be related to a potential manufacturing issue; therefore, a device history record 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: ECHELON
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• 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: 19939160
• Report Number: 2029214-2024-01396
• Device Sequence Number: 12615934
• Product Code: KRA
• UDI-Device Identifier: 00847536005969
• UDI-Public: 00847536005969
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093750
• 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): 10/24/2024

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: 03/02/2025
• Device Model Number: 105-5091-150
• Device Catalogue Number: 105-5091-150
• Device Lot Number: B526885
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 08/13/2024; 09/27/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 08/27/2024; 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2023
• 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: 24 YR
• Patient Sex: Male