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

Model Number	20012
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 of a dlp aortic root cannula with vent line, it was reported that the introducer was jammed and it was difficult for the surgeon to remove it.Use of the device was unspecified.There was no patient impact associated with this event.
Additional Manufacturer Narrative
Correction b5: a typo was noted in the additional information that was sent in the previous supplemental report for this event.The following information was provided; the surgeon stated that they were usable to use the cannula as it was stuck from first use.The correct information is as follows; the surgeon stated that they were unable to use the cannula as it was stuck from first use.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
Additional Manufacturer Narrative
Additional information b5: the device was unusable and had to be replaced to complete procedure.Medtronic received additional infor mation that the surgeon and nursing team were all unable to separate the introducer from the cannula.The surgeon stated that they were usable to use the cannula as it was stuck from first use.Product analysis: visual inspection showed the tip to be free of damage, however the male luer stem of needle introducer appeared to have been inadvertently bonded to the female luer during assembly and when it was removed the luer cracked/split.The reason for return was confirmed.Conclusion: after investigation, the complaint is confirmed for a bonded luer connector resulting in the user being unable to remove the introducer needle.This complaint is the result of a manufacturing issue, as the components were inadvertently bonded during assembly.The instructions for use do instruct the user to perform the following steps prior to insertion: "check the luer fitting connection by first holding the female luer adapter of the cannula and twisting the male luer of the needle assembly counter-clockwise.Withdraw the introducer from the cannula completely to ensure that the introducer can be withdrawn smoothly.Inspect the point on the introducer to ensure that the point has not been inadvertently bent or damaged.Carefully replace the introducer in the cannula, then re-engage the male luer and lock it into place by holding the female luer of the cannula and twisting the male luer of the needle assembly clockwise".Complaints received from july 2021 through august 2022 for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.There were no adverse patient effects because of this occurrence.Medtronic has made its supplier aware of this occurrence and will continue to monitor for future occurrences and trends.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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, CARDIOPULMONARY BYPASS
• 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: 15409463
• Report Number: 2184009-2022-00250
• Device Sequence Number: 17552938
• Product Code: DWF
• UDI-Device Identifier: 00613994495501
• UDI-Public: 00613994495501
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2022

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: 04/27/2025
• Device Model Number: 20012
• Device Catalogue Number: 20012
• Device Lot Number: 2022040939
• 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: 09/05/2022
• Supplement Date Received by Manufacturer: 09/27/2022; 11/14/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 10/24/2022; 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2022
• 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