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

Catalog Number	AMI6005
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure involving the ellipsys catheter, the device tip was observed to be rotated 45 degrees upon removal and the device gap remained at 4.5 millimeters when the button was pressed to clamp down.No fistula was created.The event occurred in the proximal radial artery.The device was safely removed from the patient.The procedure was aborted.No patient complications have been reported as a result of this event.
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: an ellipsys device was returned for evaluation.The device was returned with the tip kinked.When the device was unlocked it was not possible to open or close the jaws.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: 23416180
• Report Number: 3014251914-2025-00009
• Device Sequence Number: 21469172
• Product Code: PQK
• UDI-Device Identifier: 00763000496975
• UDI-Public: (01)00763000496975(17)260617(10)001618
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 06/17/2026
• Device Catalogue Number: AMI6005
• Device Lot Number: 001618
• 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: 10/02/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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