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

Model Number	20014
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
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 the dlp aortic root cannula with a vent line, the surgeon placed the aortic root needle into the ascending aorta without any difficulty.The cardioplegia line was connected to the cardioplegia port of the root needle and the 1/4¿ vent line was connected to the vent port on the root needle.The surgeon opened the root vent line clamp to fill the vent and there was no blood flow coming back through the vent line.The duration of cannulation was 5 minutes.The issue did not worsen over time.Upon further inspection after it was removed from the or (operating room), the perfusionist tried to inject fluid through the vent line and there was no fluid coming out of the vent port.It was suspected that the vent port was occluded with foreign material.The cannula body and tip showed no damage, and anticoagulant was used.The device was replaced to complete the case.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection showed evidence of a partial blockage in the vent line at the tubing/connector interface.During the cleaning process there was limited flow observed through the vent line.The reason for the return was confirmed for a partial blockage.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.
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.

• Brand Name: DLP AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA WITH VENT LINE
• 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: 22434553
• Report Number: 2184009-2025-00837
• Device Sequence Number: 11939270
• Product Code: DWF
• UDI-Device Identifier: 00613994495549
• UDI-Public: (01)00613994495549(17)271127(10)0230177798
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K810548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2025

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: 20014
• Device Catalogue Number: 20014
• Device Lot Number: 0230177798
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 08/22/2025; 10/16/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/16/2025; 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2024
• 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
• Patient Sex: Unknown