MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS NG 23 FR VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	96670-123
Medical Device Problem Codes	Material Deformation (2976); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: visual analysis showed evidence of damage/holes in the device.The device was cleaned and during the cleaning process there was a leak observed from the damaged area.The reason for return was confirmed.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 bio-medicus nextgen femoral venous cannula, it was reported that after the cannulation, the customer noticed that the cannula was damaged and that air was entering the cannula through it.The damage was closed with sternum wax and the procedure continued.The device was used to complete the procedure.There was no reported patient impact associated with this event.The sales rep stated that they suspected mechanical damage during cannulation.Medtronic received additional information that there was no leak observed from the cannula.The customer stated that there was no blood was leaking, but air was coming in and a transfusion was not required.The cannula was not heated or cooled prior to use.It is unknown whether there was damage in the location of the sutures.
Additional Manufacturer Narrative
Conclusion: after investigation, the complaint is confirmed for damage to the cannula body resulting in a leak during product analysis.It is unknown what may have caused this occurrence.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Complaints received from (b)(6) 2021 through (b)(6) 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 incidence.Medtronic will continue to monitor for future occurrences and trends.Correction section d manufacturer name and address: these fields have been updated.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: BIO-MEDICUS NG 23 FR VENOUS 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: 15281381
• Report Number: 9612164-2022-03159
• Device Sequence Number: 19415431
• Product Code: DWF
• UDI-Device Identifier: 00643169025967
• UDI-Public: 00643169025967
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: K180453
• 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
• Report Date (Section B): 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2025
• Device Model Number: 96670-123
• Device Catalogue Number: 96670-123
• Device Lot Number: 222451657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male