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	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
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 a dlp aortic root cannula with vent line, the team had an issue whereby the stylet would not come out of the cannula body and was stuck.The team had difficulty removing the stylet which was not an issue when they were setting up as they do not remove the stylet from the cannula in set up.This issue was noticed during the case when they were cannulating the aorta and tried to remove the stylet from the cannula body, to find the stylet was stuck and would not come out.To resolve this issue the team had to remove the aortic root cannula and put a new one in.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection showed the male luer stem of the needle introducer appeared to have been inadvertently bonded to the female luer during assembly and when it was removed the luer cracked/split.The reason for the return was confirmed.Additional information b5: medtronic received additional information that the cannula was at room temperature, neither cold or warm.There was no damage to the cannula during the pre-operative checks that were completed.The customer used the same insertion site to re-insert the cannula.After taking the cannula out, the customer used a pledgetted stitch to close it as opposed to the regular prolene stitch.Correction section e initial reporter street 1: this field has been updated.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
Fdc code updated 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: 22860164
• Report Number: 2184009-2025-00984
• Device Sequence Number: 15398472
• Product Code: DWF
• UDI-Device Identifier: 00613994495549
• UDI-Public: (01)00613994495549(17)260823(10)2023081151
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/08/2025

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: 08/23/2026
• Device Model Number: 20014
• Device Catalogue Number: 20014
• Device Lot Number: 2023081151
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 12/05/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/15/2025; 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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