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

Model Number	145-5091-150
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that two echelon microcatheters were found with damaged tips.The patient was undergoing coil embolization for treatment of an aneurysm.The accessed vessel was the femoral artery with a diameter of 3.78 mm.It was reported that coil embolization, after the echelon microcatheter was shaped, it was pushed to go upper under the guidance of the nerve guidewire and attempted to be placed into the aneurysm cavity.During the placement process, it was found that the tip of the microcatheter was obviously abnormally deformed and could not maintain its original shape.The microcatheter was then withdrawn and it was found that the tip of the microcatheter was damaged.The reported device and any accessory devices were prepared as indicated in the instructions for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 was received that the patient was being treated for a narrow-necked aneurysm in the right cavernous sinus segment, 4.5mm x 3.8mm.Vessel tortuosity was normal.The cause of the catheter damage was not determined.
Additional Manufacturer Narrative
Product analysis: as found condition: the echelon-10 catheters were returned for analysis within a shipping box, a plastic bio-pouch, and individual sealed pouches.The lot numbers of the returned echelon-10 catheters were not distinguishable.Damage location details: no damages were found with the echelon-10 catheter hub.No bends or kinks were found with the catheter body.The coating at the catheter¿s proximal marker was found damaged (bubbled).No damages were found with the catheter distal tip.The catheter distal tip was noted to be straight.No evidence of shaping was found with the catheter distal tip.Testing/analysis: none conclusion: based on the device analysis and reported information, the customer¿s ¿catheter kink/damage¿ report was confirmed as one of the returned echelon-10 catheter distal tip was found damaged (torn/broken) at the proximal edge of the catheter¿s distal marker catheter "b".The tip damage could have occurred due to excessive force or improper technique while navigating the catheter through the vessel, due to improper shaping techniques or excessive force during the shaping process.For catheter "a," no evidence of shaping was found, suggesting it might not have been shaped correctly or the incorrect device was returned.Regarding the damaged (bubbled) coating at the catheter¿s proximal marker on both catheters, it is possible the damage occurred during manufacturing or during the use of the product.However, the cause of the 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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 the tip was attempted to be shaped with steam.

• 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: 20239916
• Report Number: 2029214-2024-01595
• Device Sequence Number: 12773244
• Product Code: KRA
• UDI-Device Identifier: 00847536006256
• UDI-Public: 00847536006256
• 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
• Report Date (Section B): 11/12/2024

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: 09/26/2025
• Device Model Number: 145-5091-150
• Device Catalogue Number: 145-5091-150
• Device Lot Number: B631572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 09/17/2024
• Supplement Report FDA Received Date: 11/12/2024
• Date Device Manufactured: 09/27/2023
• 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: Male