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	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a dlp aortic root cannula with a vent line, it was reported that a blood leakage occurred from the connection to the circuit.The cannula was checked, however, there was no particular defects such as cracking or deformation observed.The device was used to complete the procedure.There was no adverse patient effect associated with this event.
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.
Additional Manufacturer Narrative
Medtronic received additional information that the cannula was not heated or cooled prior to use.There was no noticeable damage in the location of the sutures.No transfusion was required as a result of this leak.Device evaluation summary: visual inspection shows evidence of a void in the bond between the luer connector and the tubing.A syringe filled with deionized water was attached to the device and filled with the water all other openings were sealed.When the syringe was engaged there was a leak observed at the luer fitting/tubing connection.Reason for return was confirmed.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
Additional information h6.4 eval code conclusion (fdc/annex d): this field was updated.Correction d.4 unique identifier (udi) #.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: 21880014
• Report Number: 2184009-2025-00560
• Device Sequence Number: 8640871
• Product Code: DWF
• UDI-Device Identifier: 00613994495549
• UDI-Public: (01)00613994495549(17)270626(10)2024060938
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2025

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: 2024060938
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: 04/30/2025; 08/14/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 05/29/2025; 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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