MAUDE Adverse Event Report: PERFUSION SYSTEMS MC2; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	91228
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130); Hemodynamic instability (4868)
Date of Event	11/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that during use of an mc2 two stage venous cannula, it was reported during a repair of an ascending thoracic aneurysm procedure under cardiopulmonary bypass, the customer lost the venous drainage, secondary to the fracture of the venous cannula.The situation caused a vascular and hemodynamics collapse for about 2 minutes.The customer was able to resolve it in about 2 minutes.The patient bled approximately 800ml beside the cardiovascular collapse with severe hypotension and ventricular fibrillation.The use of the device was unspecified.
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.
Additional Manufacturer Narrative
Correction e1: initial reporter country and phone number updated.Correction g2: updated report source to foreign.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.
Additional Manufacturer Narrative
B.5 medtronic received additional information that the device was replaced to complete the procedure.The patient remained without heart-lung perfusion assistance for 3-4 minutes until problem was identified and resolved by replacing the cannula.The leak was from the middle of the cannula within the spiral coil.The cannula was not heated or cooled prior to use.The damage was not in the location of the sutures.It was reported that bleeding was not the problem, it was a massive air aspiration within the pump and lack of venous returned to the pump.With eventual lack of volume to return to the arterial line.There was a possibility that blood was needed eventually, but the customer could not recall those details.Medtronic received additional information that the same insertion site was used for the new cannula.E.Facility name and address updated 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: MC2
• 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: 21105972
• Report Number: 2184009-2025-00015
• Device Sequence Number: 8023151
• Product Code: DWF
• UDI-Device Identifier: 00643169463011
• UDI-Public: (01)00643169463011(17)270605(10)2024060171
• Combination Product (Y/N): N
• Initial Reporter State: PR
• PMA/510(K) Number: K140165/S001
• 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): 07/02/2025

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: 91228
• Device Catalogue Number: 91228
• Device Lot Number: 2024060171
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 04/28/2025; 06/12/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 05/22/2025; 07/02/2025
• Date Device Manufactured: 06/05/2024
• 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: Life Threatening; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White