MAUDE Adverse Event Report: PERFUSION SYSTEMS CANNULA 77208 ART ONE PIECE 8FR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	77208
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted as part of a retrospective review and remediation as part of a capa action.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
Medtronic received information that prior to use of a dlp pediatric one-piece arterial cannula, it was reported that when the customer picked the cannula and they noted that the tip was squished within the sealing edge of the package.The device was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the cannula tip was compressed in the sealing edge.It looked like the sterile seal was intact.It is unknown if the tip was obstructed because it was still in the package.It is unknown if the tip detached from the cannula body.

• Brand Name: CANNULA 77208 ART ONE PIECE 8FR
• 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: 23840596
• Report Number: 2184009-2025-01644
• Device Sequence Number: 13251371
• Product Code: DWF
• UDI-Device Identifier: 00763000091033
• UDI-Public: (01)00763000091033(17)250622(10)2022061111
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K024069
• 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
• Report Date (Section B): 12/18/2025

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 Expiration Date: 06/22/2025
• Device Model Number: 77208
• Device Catalogue Number: 77208
• Device Lot Number: 2022061111
• 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: 04/12/2023
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2022
• 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