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

Model Number	145-5091-150
Medical Device Problem Codes	Break (1069); Device Damaged by Another Device (2915); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
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 a guidewire came out of the damaged tip of the microcatheter.The patient was undergoing surgery for treatment of an aneurysm.It was noted the patient's vessel tortuosity was moderate.The access vessel was the femoral artery with a 5mm diameter it was reported that after the catheter was steam-shaped, it was inserted into the guiding catheter together with the guide wire.When it reached the internal carotid artery, it was found that the guide wire and catheter were moving abnormally.After withdrawn from the body, it was found that the tip of the microcatheter was damaged and the guide wire came out from the damaged area.The reported device and any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.
Event or Problem Description
Additional information received clarified that the guidewire did not puncture the catheter.The surgeon determined that the damage of the microcatheter caused the guidewire to come out, not that the guidewire punctured the microcatheter.The cause of the event was not determined.A stryker guidewire had been used in the procedure.
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 of 145-5091-150, lotno:b629539 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 different device¿s dispenser coil.The unknown stryker guidewire and unknown guide catheter used during the event visual inspection/damage location details: no damages were found with the echelon-10 hub.No damages or irregularities were found with the echelon-10 micro catheter body or either marker bands.The distal tip was found crushed.The tip was found kinked proximal to the distal marker band.The distal catheter appears to have been shaped.The catheter wall was found thinning and with a small puncture/rupture at the thinning/kinked location.Testing/analysis: the echelon-10 micro catheter total length (up to the proximal marker band) was measured to be ~152.6cm and the usable length was measured to be ~144.8cm, which is within specification (specification: total (ref) = 152cm, usable: 144cm ± 1.5cm).The micro catheter was flushed, and water exited the distal end only.An in-house mandrel was inserted into the echelon-10 micro catheter hub, through the catheter and became stuck at the kinked distal tip.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿difficulty navigation¿ typically could not be confirmed through device analysis.Possible causes for difficulty navigation include, but not limited to, incompatible devices, patient vessel tortuosity, damage to guidewire/catheter/guide catheter, or lack of continuous flush.Customer reported vessel tortuosity as moderate, and the devices were prepared per ifu.The customer report of ¿catheter kink/damage¿ and ¿catheter separation/break¿ were confirmed.Customer reported that the rupture/puncture was found following the difficulty navigation.It is possible that the manipulation of the guidewire/catheter during the repositioning, caused the catheter to kink.The guidewire potentially could have retracted and then puncture the catheter at the kinked location.It is also possible the damage could have occurred during the steam shaping step.Possible causes of the break are using a heat source other than steam, holding the catheter tip too close to the heat source (1 inch), not using the shaping mandrel, due to holding the device against the heat source too long (approximately 10 seconds) or removing the shaping mandrel prior to the catheter cooling following tip shaping.Thinning catheter wall due to the kinking/steam shaping would have contributed towards the break/puncture.However, the likely cause could not be determined.As the unknown guide catheter and guidewire used during the event was not returned, any contribution of the guide catheter and guidewire towards the failures could not be assessed.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: 19760938
• Report Number: 2029214-2024-01252
• Device Sequence Number: 18271209
• 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,Followup
• Report Date (Section B): 09/27/2024

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: 09/21/2025
• Device Model Number: 145-5091-150
• Device Catalogue Number: 145-5091-150
• Device Lot Number: B629539
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 07/18/2024; 08/30/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/02/2024; 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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: 50 YR
• Patient Sex: Female
• Patient Weight: 60 KG