MAUDE Adverse Event Report: PERFUSION SYSTEMS AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	11012
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of a dlp aortic root cannula, it was reported that the device had difficulty locking properly.The device was replaced.There was no patient involvement, so no adverse effect occurred.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows the locking tabs are broken off the introducer needle luer fitting.With the locking tabs broken off, the luer fitting spins freely and will not lock into position.Investigation was unable to confirm this as a manufacturing or supplier issue.It appears that after production, the device was exposed to some type of physical damage or the needle was over tightened which then broke the locking tab.Further review found no issues during the manufacturing process.This investigation was completed with the information that was provided, if additional information is received, this investigation will be reopened if deemed necessary.Note: this regulatory report is being submitted due to retrospective review through capa 624392.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: AORTIC ROOT ANTEGRADE ANTEGRADE 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: 21219285
• Report Number: 2184009-2025-00065
• Device Sequence Number: 3568800
• Product Code: DWF
• UDI-Device Identifier: 00613994495457
• UDI-Public: 00613994495457
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K790565
• 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): 01/23/2025

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: 04/12/2026
• Device Model Number: 11012
• Device Catalogue Number: 11012
• Device Lot Number: 2023040433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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