MAUDE Adverse Event Report: PERFUSION SYSTEMS BIOMEDICUS MULTISTAGE FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	96880-025
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
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 bio-medicus multi-stage femoral venous cannula with insertion kit, no issue with the guidewire was noticed when removing the wire from the packaging.When the guidewire was deployed, the tip was bending.The customer checked the wire and found that it was bending at the tip which the customer stated was not normal.The wire was still able to be used and when the cannula body was deployed over the wire there was no further issue using the cannula with the wire.The device was used to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the damage was not noticed when the device was removed from the packaging.The guidewire was not removed while the introducer needle remained in place.
Additional Manufacturer Narrative
Conclusion: after investigation at medtronic, complaint is confirmed for damage to the guidewire, however, no product has been returned to date.Photo provided by the customer appears to show there was a bend in the tip of the guide wire.As stated in the complaint the guidewire was used in the procedure and the photo appears to show there was damage in a section of the guide wire.A root cause of this occurrence cannot be determined without returned product.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Complaints received from february 2022 through march 2023 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 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: BIOMEDICUS MULTISTAGE FEMORAL 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: 16452943
• Report Number: 2184009-2023-00102
• Device Sequence Number: 14920893
• Product Code: DWF
• UDI-Device Identifier: 00763000242367
• UDI-Public: 00763000242367
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K052524
• 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): 04/05/2023

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: 05/11/2026
• Device Model Number: 96880-025
• Device Catalogue Number: 96880-025
• Device Lot Number: 2022050441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 04/05/2023
• Date Device Manufactured: 05/11/2022
• 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