MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP SINGLE STAGE VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	66128
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
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 use of dlp single stage venous cannulae, the devices were used for bi-caval cannulation for a mitral valve operation.At the end of the procedure, it was noticed that there were significant marks on one of the cannula consistent to where the tubing clamp had been applied.The marks appeared consistent with the pattern on the tubing clamp.As experienced users of this cannula, the customer had not observed this degree of indentation on the cannula post-procedure before.The customer suggested, but cannot confirm, that the tubing on the cannula was softer than usual.The cannula was not perforated, just marked.The same metal tubing clamp was used on both cannulae and the other cannula (of same lot number) was not marked.The clamp had been used for previous operations with the same devices.No damage was seen to any components or packaging before the procedure.The procedure was completed using the affected cannula so there was no interruption or delay to the operation.There was no patient impact associated with this event.Medtronic received additional information that the cannulae were not visibly softer.The cannulae were not heated or cooled prior to use.

• Brand Name: DLP SINGLE STAGE VENOUS 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: 22851450
• Report Number: 2184009-2025-00981
• Device Sequence Number: 18257285
• Product Code: DWF
• UDI-Device Identifier: 00613994878571
• UDI-Public: (01)00613994878571(17)280429(10)0231232241
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K120988
• 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): 08/20/2025

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: 66128
• Device Catalogue Number: 66128
• Device Lot Number: 0231232241
• 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: 07/24/2025
• Initial Report FDA Received Date: 08/20/2025
• Date Device Manufactured: 04/30/2025
• 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