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

Model Number	145-5091-150
Medical Device Problem Codes	Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding an echelon microcatheter that had resistance and got stuck.It was reported that the patient was undergoing an aneurysm embolization procedure.The echelon 10 microcatheter and all accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed per the ifu.The echelon was delivered smoothly to the treatment location and the first coil was delivered and deployed.However, the catheter then could not be taken back; there was a lot of resistance.Finally after struggling, the catheter was able to be retrieved and was replaced with a different echelon catheter to continue the procedure.No patient information was provided.Ancillary devices: navien 072 intermediate catheter, coils (4mm x10mm, 2.5mm x 6mm, 1.5mm x 4mm, and 2mm x 6mm).
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
H3: product analysis as found condition: an unknown medtronic pusher (coil) was returned for analysis within a shipping box, within an opened echelon-10 outer carton, within a dispenser coil and within an echelon-10 micro catheter.Visual inspection/damage location details: the pusher actuator interface was found loose and retracted from the coupler tube.The break indicator was found broken with the release wire retracted.The pusher was found bent throughout the length of the pusher.The implant coil was already detached and not returned for analysis.Customer reported the implant was implanted within the patient.No damages or irregularities were found with the echelon-10 hub.The micro catheter body was found accordioned between ~3.5cm and ~16.4cm from the proximal end and found accordioned between ~43.5cm and ~46.5cm from the proximal end.No damages or irregularities were found with the distal tip or marker bands.Blood was found within the micro catheter body.Testing/analysis: the echelon-10 total/usable length could not be reliably measured due to the severe accordioning found.The echelon-10 micro catheter was flushed, and water did not exit the distal tip as it was found occluded.The coil pusher could not be retracted out of the micro catheter as it was found stuck.The micro catheter tip outer diameter was measured to be ~0.025¿, and the outer diameter at the proximal marker band was measured to be ~0.026¿, which is within specification (specification: 0.026¿ max at tip; 0.028¿ max at proximal marker band).The echelon-10 could not be used for resistance testing within an in-house guide catheter due to the severe accordioning.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter resistance in guide catheter¿ could not be confirmed but could not be ruled out.Potential causes are patient vessel tortuosity, damaged catheter(s), flush rate too low, or multiple micro catheters used with one guide catheter.The returned pusher was found stuck within the returned echelon-10 micro catheter.The micro catheter was found accordioned and the pusher was found kinked, likely caused by attempt to retract the pusher after the implant was detached.The cause of the pusher resistance in micro catheter could not be determined.It is possible the pusher became damaged during the event, causing it to become stuck within the echelon-10 micro catheter.The actuator interface was found retracted, the break indicator was found broken, and the release wire was found retracted, detaching the implant as expected by the detachment subassemblies.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 clarifying that the device issue was the echelon got entrapped and was difficult to remove.The echelon did not have resistance in the guide catheter, but the navien used had lot number: d035317.The echelon also did not have resistance with a coil.However, 6 coils were used: 3 helix and 3 3d.No damage was observed to the echelon microcatheter after retrieval.No patient symptoms or complications were associated with this event.The procedure was completed by using an alternative echelon: d022964.
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.

• 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: 22013064
• Report Number: 2029214-2025-01175
• Device Sequence Number: 5192331
• Product Code: KRA
• UDI-Device Identifier: 00847536006256
• UDI-Public: (01)00847536006256(17)270111(10)D010080
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 09/02/2025

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 Model Number: 145-5091-150
• Device Catalogue Number: 145-5091-150
• Device Lot Number: D010080
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 06/26/2025; 08/28/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 07/07/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2025
• 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: Male