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

Model Number	77420
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
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
Medtronic received information that during use of an eopa arterial cannula, it was reported that the introducer and the dilator did not fit properly, showing different sizes.The device was replaced to complete the procedure.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
Device evaluation: visual inspection showed no outward signs of any damage.Performance analysis: the dilator outer diameter (od) and the hemostasis cap inner diameter ( id) were measured hemostasis cap id - was measured to be 0.198 inches, specification, 06688 has the id to be 0.202 +/- 0.005 inches dilator od - was measured to be 0.207 inches, specification, 06818 has the od to be 0.210 +0.002/-0.004 inches the dilator was inserted into the hemostasis cap and when the dilator tip was pushed it did not appear to move.Conclusion: reason for the return was visually confirmed.Correction.D.3 mfr name and address 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
Correction: device evaluation summary: visual inspection shows no outward signs of any damage.The dilator od and the hemostasis cap id were measured using a keyence scope.Hemostasis cap id - was measured to be 0.198 inches, specification, 06688 has the id to be 0.202 +/- 0.005 inches dilator od - was measured to be 0.207 inches, specification, 06818 has the od to be 0.210 +0.002/-0.004 inches the dilator was inserted into the hemostasis cap and when the dilator tip was pushed it did not appear to move easily it was tapped on the tip with little to no movement noted reason for the return was not confirmed.Correction h6.3 eval code result (fdr/annex c): this field was 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: 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: 23971722
• Report Number: 9617601-2026-00061
• Device Sequence Number: 12967824
• Product Code: DWF
• UDI-Device Identifier: 00763000946777
• UDI-Public: (01)00763000946777(17)280626(10)0231651594(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 04/13/2026

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: 77420
• Device Catalogue Number: 77420
• Device Lot Number: 0231651594
• 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: 01/05/2026
• Supplement Date Received by Manufacturer: 03/11/2026; 04/04/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 04/03/2026; 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2025
• 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 Age: 62 YR
• Patient Sex: Male