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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure requiring aortic cannulation for cardiopulmonary bypass using an eopa 3d arterial cannula for mitral valve surgery, a hole was observed in the wire-wound portion of the first cannula and a small blood jet was seen from that area.The estimated patient blood loss was approximately 20 ml.The leak occurred after connection to the perfusion circuit, flow was initiated but the patient was not cross clamped yet.The first cannula was removed and replaced with an identical eopa 3d arterial cannula, and the same issue occurred.A hole and leak in the same region of the wire-wound portion, was observed with the second cannula.The estimated patient blood loss for the second cannula was less than 20 ml.The second cannula was also removed and replaced.A third cannula of a different size was then used to complete the procedure.The patient required three cannulation attempts, which delayed going onto cardiopulmonary bypass by approximately 10 minutes and increased procedure time.There was also an increased risk of complications associated with repeated cannulation.No additional fluid or blood transfusion was required.No clamps were p laced on the wire-wound portion, the cannulae were not heated or cooled, and there was no obvious damage to the packaging or other portions of the cannulae.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.

• 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: 24938197
• Report Number: 3003955307-2026-00042
• Device Sequence Number: 18809281
• Product Code: DWF
• UDI-Device Identifier: 00199150023257
• UDI-Public: (01)00199150023257(17)290112(10)0232798416(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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: 0232798416
• 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: 04/09/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2026
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 64 KG