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

Model Number	77520
Medical Device Problem Codes	Mechanical Problem (1384); Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
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
Medtronic received information that during use of an eopa arterial cannula, it was reported that the customer fully assembled the device and noticed that the white introducer did not protrude from the cannula body as normal.The customer felt that it would cause an issue at cannulation.The procedure commenced with only a few minutes of delay but there was no patient impact as a result of the delay.The customer suspected that the cannula body was too long or the white introducer was too short from manufacturing.The device was replaced to complete the procedure.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
Updated information b5: medtronic received information that prior to use of an eopa arterial cannula, it was reported that the customer fully assembled the device and noticed that the white introducer did not protrude from the cannula body as normal.The customer felt that it would cause an issue at cannulation.The procedure commenced with only a few minutes of delay but there was no patient impact as a result of the delay.The customer suspected that the cannula body was too long or the white introducer was too short from manufacturing.The device was replaced to complete the procedure.There was no patient involvement, so no adverse effect occurred.Updated additional codes: imf (annex f) health impact.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 that the dilator does not protrude out from the tip correctly.The cannula length was measured using a caliper and the dilator length was measured using a ruler with the following results.Cannula length was measured to be 10.544 inches, the specification has the length to be 10.544 to 10.624 inches.Dilator length was measured to be approximately 12.9 inches, the specification has the cut length as a reference dimension from 13.241 to 13.365 inches.Reason for 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
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): 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: 20332227
• Report Number: 2184009-2024-00570
• Device Sequence Number: 15846485
• Product Code: DWF
• UDI-Device Identifier: 00763000135546
• UDI-Public: 00763000135546
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 04/23/2025

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: 77520
• Device Catalogue Number: 77520
• Device Lot Number: 2024050866
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 10/10/2024; 11/14/2024; 04/22/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/31/2024; 11/28/2024; 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2024
• 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