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

Catalog Number	AMI6005
Medical Device Problem Codes	Difficult to Remove (1528); Positioning Problem (3009)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Perforation of Vessels (2135)
Date of Event	04/02/2024
Type of Reportable Event	Serious Injury
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 ellipysis catheter with a 10cm 6fr non-medtronic sheath and an 80cm 014 nitrex guidewire during treatment of a soft tissue lesion in the patients right proximal forearm artery and vein.Moderate vessel tortuosity and minimal vessel calcification were reported.Artery/vein diameter reported as >2mm.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.There were no issues noted when removing the device from the hoop/tray.The ifu (instruction for use) followed during preparation, procedure, post-procedure without issue.Embolic protection was not used.The vessel was not pre or post dilated.The device was not passed through a previously deployed stent.Severe resistance was encountered when advancing the device.Excessive force was used.The distance between the artery and vein was 1.3mm.The catheter was unable to cross and removal difficulties were reported.Physician used a blade to help removal.Vessel damage was reported.The vein was torn while trying to remove sheath and catheter.After the device and sheath were removed, a pta balloon was used to stop bleeding and hematoma at removal site.A fistula was created.
Additional Manufacturer Narrative
Additional information: patient had surgery to fix the artery and vein.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 catheter tip is entangled in the sheath and is severely bent.As evident in the procedural analysis, the jaws fully closed prior to the attempted procedure.The sheath was not fully seated onto the catheter sheath bump as instructed in the ifu, and the jaws were closed on the sheath while inside the patient.Ifu was not followed.The extent of sheath entanglement in the jaws and severe bending made troubleshooting gap issues and thermal cycle testing impossible.Still image evaluation 11 images were provided for evaluation.One image shows the pouch label and the lot number 001379 indicated on the label is consistent with the lot number provided.One image shows the pouch for a non-medtronic introducer sheath.The other image shows the ellipsis catheter loaded on a sheath and damage can be observed to the tip of the device.Biologics can be observed in the jaws/on the device.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: 19164204
• Report Number: 3014251914-2024-00008
• Device Sequence Number: 7856032
• Product Code: PQK
• UDI-Device Identifier: 00763000496975
• UDI-Public: 00763000496975
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 07/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2025
• Device Catalogue Number: AMI6005
• Device Lot Number: 001379
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 04/24/2024; 07/01/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/01/2024; 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 62 KG