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

Model Number	77420
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during implant of the eopa arterial cannula, the internal white dilator was very loose and slipped out.The device was replaced to complete the procedure.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.
Additional Manufacturer Narrative
Medtronic received additional information that the dilator did not fall into the patient.Device evaluation summary: visual inspection shows no outward signs of any damage.The introducer outer diameter (od) was measured using a keyence scope and the red hemostasis cap inner diameter (id) was measured using a plug gage.Introducer od was measured to be 0.206 inches, the specification has the od to be 0.210 +0.002 / - 0.004 inches.Red hemostasis cap id was measured to be 0.199 inches, the specification has the id to be 0.202 to +/- 0.005 inches.The introducer was inserted and removed with no loose issue noted.Reason for the return was not 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 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: 22792753
• Report Number: 2184009-2025-00944
• Device Sequence Number: 8634279
• Product Code: DWF
• UDI-Device Identifier: 00763000946777
• UDI-Public: (01)00763000946777(17)280303(10)0230798431(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/05/2025

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: 77420
• Device Catalogue Number: 77420
• Device Lot Number: 0230798431
• 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: 08/11/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2025
• 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
• Patient Sex: Unknown