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); Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician attempted to use an ellipsys catheter with an ellipsys 6fr sheath and a.014 nitrex guidewire during treatment of the patients left cephalic vein.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) was followed during preparation, procedure, post-procedure without issue.Embolic protection was not used.The vessel was not post dilated.The distance between artery and vein greater was less than 1.5mm.It was reported physician had the device in the sheath, but nothing was activated.The sheath popped out and physician tried to pull out the device in order to put the dilator back on the wire and push the sheath back in.When physician tried to pull out the device from the sheath, it got caught on the end of the sheath and they both wouldn't come out.Physician had to do a minor cut down in order to take out the sheath and device.A replacement ellipsys sheath and catheter were used to complete procedure.A fistula was created.
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: the device returned for evaluation with a sheath was entangled in the jaws and the catheter was bent.Procedure analysis shows thermal cycle was not ran, which aligns with the complaint.An attempt was made to close the jaws which were likely prevented by the sheath entanglement.It was not possible to remove the sheath from the catheter tip without damaging the catheter tip.In an attempt to analyze without further bending to the shaft the tip and sheath were cut off the returned device.The closing gap value read 408 on a power controller showing the shaft was too bent to fully close.The handle was opened, and no issue was found with the soldering.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: 19049171
• Report Number: 3014251914-2024-00006
• Device Sequence Number: 8471818
• Product Code: PQK
• UDI-Device Identifier: 00763000496975
• UDI-Public: 00763000496975
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 06/25/2024

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: 08/15/2024
• Device Catalogue Number: AMI6005
• Device Lot Number: 001156
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 06/25/2024
• Date Device Manufactured: 08/15/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: .014 NITREX GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male