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

Model Number	190-5091-150
Medical Device Problem Codes	Leak/Splash (1354); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
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 after opening the package for hydration, it was found that the proximal end of the microcatheter was leaking water.Replacing the product to complete the surgery.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 treatment of an aneurysm.It was noted the patient's vessel tortuosity was normal.The access vessel was the femoral artery with a diameter of 7mm.
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 was received that there was no damage or evidence of tampering to device packaging.The package was opened and device hydrated when leakage was found.Hydration was performed prior to the leak being seen.
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 and within a sealed plastic biohazard pouch.Visual inspection/damage location details: no damages or irregularities were found with the echelon-10 hub.No damages or irregularities were found with the outer and inner strain relief.No bends or kinks were found with the echelon-10 catheter body.No damages were found with the echelon-10 distal tip or marker bands.Testing/analysis: the echelon-10 total length was measured to be ~152.5cm and the useable length was measured to be ~144.6cm, which is within specification (specification: total (ref) = 152cm; usable = 144.0 cm ± 1.5cm).The echelon-10 micro catheter was flushed, and water was observed exiting from under the inner strain relief.The outer and inner strain relief was removed.The catheter was found with skive damage under the strain relieves (figure f and g).Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter leak¿ was confirmed.The leak was found due to skive damage found under the strain relief.The outer and inner strain reliefs were found undamaged.Therefore, the skive damage likely occurred during manufacturing.There is an indication that the event could be related to a 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: 19483368
• Report Number: 2029214-2024-01045
• Device Sequence Number: 8335957
• Product Code: KRA
• UDI-Device Identifier: 00847536006294
• UDI-Public: 00847536006294
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/06/2024

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: 04/27/2025
• Device Model Number: 190-5091-150
• Device Catalogue Number: 190-5091-150
• Device Lot Number: B556560
• 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: 06/05/2024
• Supplement Date Received by Manufacturer: 06/14/2024; 07/25/2024; 09/06/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 07/10/2024; 08/21/2024; 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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: 48 YR
• Patient Sex: Unknown