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

Model Number	96880-025
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that during use of a bio-medicus multi-stage femoral venous cannulae with insertion kit, it was reported that during de-cannulation, the tip of the cannula broke in the vessel, and emigrate right up in the atrium. use of device was unspecified.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
Medtronic received information that during use of a bio-medicus multi-stage femoral venous cannula with insertion kit, it was reported that during de-cannulation, the tip of the cannula broke in the vessel, and emigrate right up in the atrium.The device was not replaced as the issue occurred at the decannulation moment, after coming off bypass.Medtronic received additional information that the tip was not obstructed.The customer stated that a portion of 7 to 8cm of the tip detached from the cannula body.The tip was recovered as the tip had migrated through the inferior vena cava (ivc) into the auricle (ra), from where it was taken out.The customer made an incision on/in the ra and the tip was removed with a long pean clamp through that incision, from the junction point of the ivc to the ra, right before entering into the ra.The cannula was not heated or cooled prior the use as it was stored at room temperature.The patient was discharged from the hospital 5 days post-operation without any kind of complications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: BIOMEDICUS MULTISTAGE FEMORAL VENOUS 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: 20289786
• Report Number: 2184009-2024-00561
• Device Sequence Number: 15256200
• Product Code: DWF
• UDI-Device Identifier: 00763000242367
• UDI-Public: 00763000242367
• Combination Product (Y/N): N
• 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): 10/18/2024

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 Model Number: 96880-025
• Device Catalogue Number: 96880-025
• Device Lot Number: 2023120670
• 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: 09/20/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2023
• 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; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 90 KG