MAUDE Adverse Event Report: PERFUSION SYSTEMS CANNULA 87024 ART CUR TIP 24FR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	87024
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that prior to use, during preparation for extracorporeal circulation it was reported this dlp curved tip arterial cannula with wirewound body had blood flowing between the inner and outer cannula layer.  the device was used to complete the procedure.There was no patient involvement, so no adverse effect occurred.
Additional Manufacturer Narrative
Conclusion: after investigation the complaint is confirmed for blood flowing between the inner and outer cannula layer.It appears that the cannula body wall could have delaminated, however, 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.Trends for issues with this device are monitored.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: medtronic received additional information stating that the cannula was not heated or cooled prior to use.The damage was not in the location of the sutures.The amount of blood lost as a result of the leak could not be provided.A transfusion was not required because of the leak.The leak was from the cannula.The leak was observed when the cannula was inserted into the patient.Device evaluation summary: visual inspection shows evidence of blood residue around a section of the wire inside the device.Additional visual inspection shows damage / hole in the device and some deformity at both ends.Reason for return was confirmed.Correction: the cannula was replaced with a new cannula from the same lot, and this cannula was used to complete the procedure without problems.There was no patient involvement, so no adverse effect occurred.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: CANNULA 87024 ART CUR TIP 24FR
• 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: 14157307
• Report Number: 2184009-2022-00082
• Device Sequence Number: 2944203
• Product Code: DWF
• UDI-Device Identifier: 00643169083035
• UDI-Public: 00643169083035
• Combination Product (Y/N): N
• PMA/510(K) Number: K840002
• 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): 06/29/2022

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: 04/21/2024
• Device Model Number: 87024
• Device Catalogue Number: 87024
• Device Lot Number: 2021040698
• 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: 03/23/2022
• Supplement Date Received by Manufacturer: 04/26/2022; 06/02/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/24/2022; 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2021
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 96 KG