MAUDE Adverse Event Report: AVENU MEDICAL ELLIPSYS CATHETER; PERCUTANEOUS CATHETER FOR CREATION OF AN ARTER

Catalog Number	AMI6005
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
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
Physician attempted to use an ellipsys catheter and power controller with a 6fr sheath and a 014 nitrex wire for treatment of the patients proximal median cubital vein to proximal radial artery in arm.A 5x20x90 non-medtronic balloon was used for post creation dilation, using a syringe to expand it.Embolic protection was not used/not needed, no stents were present in the access site and there was no resistance when putting the catheter through the sheath from our access kit.However, the power controller did show a reading of 3.4 when they closed the jaws.It was reported that there was a warning ¿gap sensor error catheter replacement recommended¿ displayed.Physician proceeded with procedure because they were comfortable with what they saw on ultrasound.During removal, the did have to activate another cycle to remove the catheter because it would not remove.The device was removed with no harm to the patient and anastomosis successfully created.The patient will come back for their standard 2 week follow up for patency assessment and maturation planning.No patient injury reported.
Additional Manufacturer Narrative
Product analysis: the tip of the catheter was bent.The body of the catheter was bent.An attempt was made to straighten the catheter prior to testing.The catheter was connected to the power controller and an error message ¿catheter defective¿ was displayed on the controller.This error is likely due to the extreme bending of the shafts internally resulting in magnet misalignment.The handle was opened and a bend could be observed to the internal shaft.Procedural analysis shows the power controller was restarted 3 times.The catheter jaws were closed, then restarted an additional 4 times, this aligns with complaint text regarding troubleshooting.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: ELLIPSYS CATHETER
• Common Device Name: PERCUTANEOUS CATHETER FOR CREATION OF AN ARTER
• Manufacturer (Section D): AVENU MEDICAL; 27123 calle arroyo; #2101; san juan capistrano CA 92675
• Manufacturer (Section G): AVENU MEDICAL; 27123 calle arroyo; #2101; san juan capistrano CA 92675
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 20704890
• Report Number: 3014251914-2024-00015
• Device Sequence Number: 15537321
• Product Code: PQK
• UDI-Device Identifier: 00763000496975
• UDI-Public: 00763000496975
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K191114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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: 02/10/2025
• Device Catalogue Number: AMI6005
• Device Lot Number: 001341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 01/17/2025
• Date Device Manufactured: 02/10/2023
• 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: Unknown