MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	77116
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976); Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
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 the arterial cannula was difficult to insert because the tip is not rounded.The customer reported arterial can nulation failure and stated that the mandrel is mobile and sinks into the lumen of the cannula at the slightest pressure.The customer attempted to reposition after re-blocking the mandrel, then performed a cannulation with a cannula of the same range but in a sma ller size.There were no known patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information b5.Medtronic received additional information that the cannula has not been heated or cooled.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
Correction b5.It was reported that the dlp pediatric one-piece arterial cannula was difficult to insert because the tip is not rounded.The customer reported arterial cannulation failure and stated that the mandrel is mobile and sinks into the lumen of the cannula at the slightest pressure.The customer attempted to reposition after re-blocking the mandrel, then performed a cannulation with a cannula of the same range but in a smaller size.No patient complications have been reported as a result of this event.Medtronic received additional information that the cannula has not been heated or cooled.Medtronic received additional information that the same insertion site was used for the replaced cannula.Medtronic received additional information that the cannula nozzle tip was the affected part.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 the obturator tip is rounded.The obturator was inserted into the cannula and with minimal force it slid back inside the cannula.The blue obturator hub was inserted and removed from the plug cap several times with no friction noted.The device was cut apart to measure the components.The obturator hub od and the plug/cap id were measured using a keyence scope.Obturator hub od was measured to be 0.254 inches, the specification (b)(4) has the od to be 0.258 +0.005 / - 0.004 inches obturator plug/cap id was measured to be 0.256 inches, the specification (b)(4) has the id to be 0.255 to 0.257 inches reason for the return was confirmed a manipulation issue.Correction d3: manufacturer name and manufacturer city updated additional info d9: device return date updated and device evaluation availability updated additional info h6: updated the annex b and annex c codes 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: ARTERIAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr; minneapolis MN 55428
• Manufacturer (Section G): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr; minneapolis MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22803836
• Report Number: 2184009-2025-00958
• Device Sequence Number: 18354454
• Product Code: DWF
• UDI-Device Identifier: 00763000091200
• UDI-Public: (01)00763000091200(17)260601(10)2023060306
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K024069
• 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): 11/20/2025

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: 06/01/2026
• Device Model Number: 77116
• Device Catalogue Number: 77116
• Device Lot Number: 2023060306
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 09/30/2025; 10/29/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/05/2025; 10/22/2025; 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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