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

Model Number	145-5091-150
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024 mpxr 1226034 (rep, hcp, for): medtronic received information that an echelon catheter tip broke.During the aneurysm surgery the echelon microcatheter was pre-shaped.The tip of the microcatheter broke and a new microcatheter was replaced to complete the surgery.The catheter was ruptured intact in the distal location.There was no friction or difficulty during delivery.There was no other damage to the catheter.The devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as per ifu.The patient was being treated for an aneurysm in the right femoral artery.No patient symptoms or complications were reported.
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.The cause of the catheter rupture was not determined.This event¿did not required¿medical intervention.The surgery was completed by replacing the catheter, no adverse effect on the patient.The tip detachment occurred when they pre-shaped the catheter.No pushing was performed.It did not enter the human¿s body.
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 #707035888: equipment used: video inspection system (m-85519), ruler (m-83361) 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.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.The distal ~1.8cm of the micro catheter was found shaped (figure d <(><<)>(><(>&<)><(><<)>)> e).The catheter was found melting at this location (figures e <(><<)>(><(>&<)><(><<)>)> d).The distal tip and marker band were found undamaged.The catheter wall was found stretched and thinning proximal to the distal marker band (figure f).A partial break was found also found proximal to the distal marker band (figure g).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 (up to the proximal marker band) was measured to be ~145.0cm, 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 hub, through the micro catheter and became stuck at the broken location.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿catheter rupture¿ could not be confirmed but the catheter was found with a ¿catheter separation/break¿.Customer reported that the break was found during tip shaping.In addition, the catheter body was found with severe heat damage (melting) and a portion of the catheter wall thinning/stretched.Possible causes of the break and catheter melting/thinning are using a heat source other than steam, holding the catheter tip too close to the heat source (1 inch), due to holding the device against the heat source too long (approximately 10 seconds) or removing the mandrel prior to letting the micro catheter cool.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: 20330601
• Report Number: 2029214-2024-01705
• Device Sequence Number: 8003639
• 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): 01/02/2025

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 Expiration Date: 08/20/2025
• Device Model Number: 145-5091-150
• Device Catalogue Number: 145-5091-150
• Device Lot Number: B614032
• 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: 09/25/2024
• Supplement Date Received by Manufacturer: 10/08/2024; 12/06/2024
• Initial Report FDA Received Date: 09/29/2024
• Supplement Report FDA Received Date: 10/30/2024; 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2023
• 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 Sex: Male