MAUDE Adverse Event Report: MEDTRONIC GRAND RAPIDS EOPA ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	77418
Medical Device Problem Codes	Contamination (1120); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the eopa arterial cannula product exhibited an appearance of three white dots and tip damage.The use of the device was unspecified.No patient complications have been reported as a result of 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
Additional info b5: the device was used to complete the procedure additional info b5: medtronic received additional information that the tip did not detach from the cannula body.The cannula was not heated or cooled prior to use.Correction d3: manufacturer name, street, city, region, and post code all 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
Additional info b5: medtronic received additional information that the tip was not damaged but the cannula body was damaged 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 b5: medtronic received additional information that the customer cut and created a damage in order to examine the cannula clearly.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 showed the device was cut into two sections when it was received and there was evidence of a couple of white spots.The 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 information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.The damaged cannula body was caused by the surgeon, as the surgeon cut and created the damage so as to examine the reported 3 white dots issue reported.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803.Reports sent under 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 eopa arterial cannula product exhibited an appearance of three white dots and tip damage.The device was used to complete the procedure.See the attached photos.No patient complications have been reported as a result of this event medtronic received additional information that the tip did not detach from the cannula body.The cannula was not heated or cooled prior to use.Medtronic received additional information that the tip was not damaged but the cannula body was damaged.Medtronic received additional information that the customer cut and created a damage in order to examine the cannula clearly.Medtronic received additional information that the white spot issue is the only issue being reported and these white spots were observed when device was inserted.

• Brand Name: EOPA ARTERIAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): MEDTRONIC GRAND RAPIDS; 620 watson sw; grand rapids,mi MN 49504
• Manufacturer (Section G): MEDTRONIC GRAND RAPIDS; 620 watson sw; grand rapids,mi MN 49504
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24386320
• Report Number: 2184009-2026-00270
• Device Sequence Number: 10289100
• Product Code: DWF
• UDI-Device Identifier: 00763000135614
• UDI-Public: (01)00763000135614(17)281020(10)0232538802(20)03
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K031037
• 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,Followup
• Report Date (Section B): 04/24/2026

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: 77418
• Device Catalogue Number: 77418
• Device Lot Number: 0232538802
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 02/20/2026; 02/23/2026; 03/24/2026; 04/16/2026; 04/20/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 02/23/2026; 02/24/2026; 04/16/2026; 04/17/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2025
• 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