MAUDE Adverse Event Report: PERFUSION SYSTEMS CANNULA 70424 ART FLEX ARCH 24FR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	70424
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/28/2025
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
Medtronic received information that during use of a dlp flexible arch arterial cannula, it was reported that there was a leakage.The device was used to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the customer sutured the device to stop the leak.The leak is from the cannula.The cannula was not heated or cooled prior to use.The cannula tip was damaged.The amount of patient blood loss could not be provided.A transfusion was required but not because of the leak.The cannula was experiencing instability in the bearing (tip of the cannula) which caused leakage during aortic candation.

• Brand Name: CANNULA 70424 ART FLEX ARCH 24FR
• 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: 22086157
• Report Number: 2184009-2025-00691
• Device Sequence Number: 12496530
• Product Code: DWF
• UDI-Device Identifier: 00643169485921
• UDI-Public: 00643169485921
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K840001
• 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): 05/27/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 70424
• Device Catalogue Number: 70424
• Device Lot Number: 2024050997
• 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: 04/30/2025
• Initial Report FDA Received Date: 05/27/2025
• Date Device Manufactured: 05/16/2024
• 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 Age: 57 YR
• Patient Sex: Male
• Patient Weight: 70 KG