MAUDE Adverse Event Report: MEDTRONIC GRAND RAPIDS EOPA 3D ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	78322
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This complaint record has been created to capture the seven eopa 3d arterial cannulae returned on complaint event (b)(4).Parent event has been reported by customer for cannula leaked out of the side while it was inserted into the aorta.The products involvedwith this complaint have not been used and returned for analysis only.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows evidence of damage/split.Pressure integrity testing was performed at 0.5 l/pm with 5 psi, (258 mmhg) of backpressure for 10 min.During the pressure integrity test there was a leak observed at the damage/split.Reason for the return was confirmed.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: EOPA 3D ARTERIAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): MEDTRONIC GRAND RAPIDS; 620 watson sw; grand rapids MI 49504
• Manufacturer (Section G): MEDTRONIC GRAND RAPIDS; 620 watson sw; grand rapids MI 49504
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 25227558
• Report Number: 3003955307-2026-00093
• Device Sequence Number: 13262311
• Product Code: DWF
• UDI-Device Identifier: 00199150023257
• UDI-Public: (01)00199150023257(17)290122(10)0232862784(20)01
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K260195
• 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
• Report Date (Section B): 05/20/2026

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 Model Number: 78322
• Device Catalogue Number: 78322
• Device Lot Number: 0232862784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/20/2026
• Date Device Manufactured: 01/23/2026
• 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