MAUDE Adverse Event Report: PERFUSION SYSTEMS CANNULA 88020 ART CUR TIP 20FR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	88020
Medical Device Problem Codes	Obstruction of Flow (2423); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
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 the dlp curved tip arterial cannula, a pressure drop was observed.The tip of the cannula was found to be kinked, resulting in only 25% of the lumen being available.The surgeon verified the position of the cannula and then decided to change it.Upon removal; the kinked tip and reduced lumen were confirmed.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Medtronic received additional information that the cannula was not heated or cooled prior to use.The kink was not in the location of the sutures.It was located at the tip of the cannula.Medtronic received additional information that the aortic pressure rose to 42% for a theoretical patient flow rate of 2.5 l/min.It noticed that the cannula was folded at its end, causing an obstruction of three-quarters of the lumen of the cannula.Correction d.3 mfr name and mfr city 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
Device evaluation summary: visual inspection shows evidence of a deformity in the tip and cracks in the connector.Reason for the 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 info h6: annex d 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: CANNULA 88020 ART CUR TIP 20FR
• 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: 22662448
• Report Number: 2184009-2025-00895
• Device Sequence Number: 7607566
• Product Code: DWF
• UDI-Device Identifier: 00643169485624
• UDI-Public: (01)00643169485624(17)261221(10)2023121011
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K840002
• 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,Followup
• Report Date (Section B): 11/21/2025

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: 88020
• Device Catalogue Number: 88020
• Device Lot Number: 2023121011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 07/30/2025; 09/04/2025; 11/21/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/26/2025; 10/01/2025; 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2023
• 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