MAUDE Adverse Event Report: MEDTRONIC MEXICO BIO-MEDICUS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	96370-023
Medical Device Problem Codes	Mechanical Problem (1384); Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
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 one-piece femoral venous cannula, it was reported that the ecmo (ext racorporeal membrane oxygenation) retrieval team picked up the patient from a regional service.The retrieval team cannulated the patient to commence ecmo.However, they discovered that they could not connect the cannula to the ecmo circuit due to a half-inch connector, rather than the standard 3/8 connector.The patient had to be re-cannulated with a different cannula that had a 3/8 connector.The patient was successfully attached to the ecmo circuit.The patient was a critically unwell patient.The device was replaced to complete the procedure.There was no adverse patient effect associated with this event.

• Brand Name: BIO-MEDICUS
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22553503
• Report Number: 9612164-2025-03533
• Device Sequence Number: 9700574
• Product Code: DWF
• UDI-Device Identifier: 00613994504777
• UDI-Public: (01)00613994504777(17)270329(10)2023031610
• Combination Product (Y/N): N
• PMA/510(K) Number: K924642
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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 Model Number: 96370-023
• Device Catalogue Number: 96370-023
• Device Lot Number: 2023031610
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2023
• 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
• Patient Sex: Unknown