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

Model Number	77620
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows no outward signs of any damage.The porous plug was not able to be removed from either device.Reason for return was confirmed.Conclusion: after investigation at medtronic, complaint is confirmed for not being able to remove the porous plug.It is unknown what may have caused this occurrence.Additional visual inspection of the two returned devices did not see any signs of damage to the product.The attempt to remove the plug from each device was unsuccessful.Additional inspection was performed after one of the hubs was cut to check if there was the appearance of solvent.No solvent was observed.The plug was securely inserted into hub and could not be removed.There was no partial carton in inventory for this lot.A pouched product from partial carton was opened and compared to the returned device.It was observed that the white porous plug on the returned device was extended further out of the hub as compared to the one from the partial carton.The incoming inspection for theporous plug vendor lot used in this complaint passed the required visual, dimensional and functional testing.Vendor component hub lot used in this complaint does not require an inspection, only a documentation check.In not being able to remove the plugs the od at the tip end of the plug and id of the hub could not be performed.This would have helped to determine if possibly one of the components was out of tolerance or a stack up issue.All processing documentation reviewed shows this device did meet the required manufacturing and quality processing checks.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.A review of complaints for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.There were no adverse patient effects as a result of this incidence.Medtronic has made its supplier aware and will continue to monitor for future occurrences and trends.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use at the beginning of the bypass, the customer reported the surgeon could not use the eopa arterial cannula guide as he could not remove the cannulae caps, as they were stuck on.Device was replaced to complete the case.There was no adverse effect to the patient.

• 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: 17004055
• Report Number: 2184009-2023-00339
• Device Sequence Number: 7168717
• Product Code: DWF
• UDI-Device Identifier: 00763000135669
• UDI-Public: 00763000135669
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 05/25/2023

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: 01/31/2023
• Device Model Number: 77620
• Device Catalogue Number: 77620
• Device Lot Number: 2020011518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2020
• 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