MAUDE Adverse Event Report: PERFUSION SYSTEMS EOPA ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	77422
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/07/2025
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
It was reported that during cardiac surgery, the white "dead-ender" cap on the eopa arterial cannula came off twice.Prior to the procedure, both the registered nurse and the surgeon had tightened the cap.Shortly after initiation of cardiopulmonary bypass, the cap detached from the cannula.The surgeon re-secured and tightened the cap, but it detached again soon after.The surgical team then replaced the cap with a one-way stopcock on the cannula, after which no further issues occurred.Both instances resulted in blood loss and delays to the surgical procedure while the issue was resolved.Medtronic received additional information that the cap was not damaged prior to use.No unplanned blood transfusion was required.Medtronic received additional information that the surgeon and the perfusionist both confirmed that there was less than 50mls of blood loss as they were able to catch and resolve it immediately.
Additional Manufacturer Narrative
Device evaluation: visual inspection shows no outward signs of any damage.The cannula luer port taper was measured using a taper gauge, the luer cap taper was measured using a ring gauge both were found to be in specification.Pressure integrity testing was performed at 3 l/min with 15 psi, (775 mmhg) of back pressure for 10 minutes.During the pressure integrity testing the luer cap remained connected.Conclusion: reason for the return was not confirmed.Correction b.2.Intervention required correction h.1.Serious injury correction imf code updated.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 ARTERIAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23654440
• Report Number: 2184009-2025-01531
• Device Sequence Number: 4770423
• Product Code: DWF
• UDI-Device Identifier: 00763000946784
• UDI-Public: (01)00763000946784(17)280723(10)0231793197(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K031037
• 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): 01/15/2026

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: 77422
• Device Catalogue Number: 77422
• Device Lot Number: 0231793197
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2025
• 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 Sex: Unknown