MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS EOPA 3D Vented Arterial Cannula; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	78220
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction

• Brand Name: EOPA 3D Vented Arterial Cannula
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr; minneapolis,mn
• Manufacturer (Section G): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr; minneapolis,mn
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50857341
• Report Number: 2184009-2026-01396
• Device Sequence Number: 15940969
• Product Code: DWF
• UDI-Device Identifier: 00763000135690
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K260195
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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
• Device Model Number: 78220
• Device Catalogue Number: 78220
• Device Lot Number: 2024011291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown