MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV BIO-MEDICUS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	CB96570-015
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a bio-medicus nextgen femoral arterial cannula, it was reported that the model of the 15f arterial cannula did not match the model indicated on the external packaging. on the morning, at 9:30 a.M., an out-of-hospital endoscopic retrograde cholangiopancreatography (ercp) procedure was performed for a family case, and ecmo (extracorporeal membrane oxygenation) was initiated to maintain circulation.The chief surgeon instructed the team to prepare a 21f venous cannula and a 15f arterial cannula for vascular puncture according to the patient's condition.During the verification process for the high-value arteriovenous cannula, it was found that the model of the 15f arterial cannula did not match the model indicated on the external packaging (the packaging indicated 15f, but the cannula inside the box was a blue-tipped 17f venous cannula).The circulating nurse immediately reported this to the chief surgeon. the device was replaced with the backup 17f arterial cannula. the procedure was completed, the patient was transferred, and returned to our department.The customer stated that this event posed a significant surgical safety risk and could easily lead to serious adverse consequences. there was no adverse patient effect associated with this event.
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 b5: medtronic received information that prior to use of a bio-medicus nextgen femoral arterial cannula, it was reported that the model of the 15f arterial cannula did not match the model indicated on the external packaging.  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
Medtronic received additional information that the external packaging referred to external shipping box.The problem was discovered without use and did not affect the patient 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: BIO-MEDICUS
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23463721
• Report Number: 9617601-2025-02478
• Device Sequence Number: 10408095
• Product Code: DWF
• UDI-Device Identifier: 00763000193355
• UDI-Public: (01)00763000193355(17)260415(10)228543775
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K142673
• 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): 12/18/2025

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 Expiration Date: 04/15/2026
• Device Model Number: CB96570-015
• Device Catalogue Number: CB96570-015
• Device Lot Number: 228543775
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 12/04/2025; 12/17/2025
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/17/2025; 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2024
• 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
• Patient Age: 27 YR
• Patient Sex: Unknown