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

Model Number	77522
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2025
Type of Reportable Event	Malfunction
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 a procedure involving these eopa arterial cannulae, the customer attempted to use the first cannula, however, there was an alleged product issue where the white introducer kept pushing back during cannulation.As a result, the first cannula was replaced.The second cannula, allowed cannulation, however as the introducer was withdrawn, blood started to leak out as if the introducer had not formed a seal.The cannulae were not cooled or heated and there was no visible damage to the cannulae or packaging.There was minimal blood loss of approximately 20mls and no fluid or blood transfusion was required.The second cannula was used to complete the procedure.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows no outward signs of any damage.The dilator od was measured using a keyence scope and the hemostasis cap id was measured using a plug gage.Dilator od - was measured to be 0.239 inches, specification, 06819 has the od to be 0.242 +0.002/-0.004 inches hemostasis cap id - was measured to be 0.230 inches, specification has the id to be 0.225 +/- 0.005 inches the dilator was inserted through the cap and out the tip of the cannula.A force was applied to the tip of the introducer with no pushing back observed.Reason for the return was not confirmed.Additional information h6.2 eval code method (fdm/annex b): this field was updated.Additional information h6.3 eval code result (fdr/annex c): this field was 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: 23955339
• Report Number: 2184009-2026-00004
• Device Sequence Number: 5739564
• Product Code: DWF
• UDI-Device Identifier: 00763000135553
• UDI-Public: (01)00763000135553(17)280521(10)0231401273
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/05/2026

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: 77522
• Device Catalogue Number: 77522
• Device Lot Number: 0231401273
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/22/2025
• 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