MAUDE Adverse Event Report: PERFUSION SYSTEMS AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	20012
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a 20012 dlp aortic root cannula, the customer reported that upon insertion of the cannula, the surgeon could not remove the stylet, it was stuck.The entire cannula was removed and replaced with same medtronic cannula to complete the procedure with no issue.There was no patient impact associated with this event.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows the tip to be free of damage, however, the male luer stem of needle introducer appears to have been inadvertently bonded to the female luer during assembly and when it was removed the luer cracked/split.Cannula is not considered functional.Reason for return was confirmed.Conclusion: after investigation at medtronic, complaint is confirmed for bonded luer connector.This complaint is the result of a manufacturing issue - as the components were inadvertently bonded during assembly.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Complaints received from june 2020 through august 2021 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 (b)(4) 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.

• Brand Name: AORTIC ROOT ANTEGRADE ANTEGRADE 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: 16991504
• Report Number: 2184009-2023-00325
• Device Sequence Number: 15213714
• Product Code: DWF
• UDI-Device Identifier: 00613994495501
• UDI-Public: 00613994495501
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K810548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/24/2023

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: 01/06/2024
• Device Model Number: 20012
• Device Catalogue Number: 20012
• Device Lot Number: 2021010334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2021
• 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