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

Model Number	96880-019
Medical Device Problem Codes	Crack (1135); Mechanical Problem (1384)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during use of a bio-medicus multi-stage femoral venous cannula with insertion kit, a guide wire (0.97mm x 180cm) for the cannula was being used to cannulate a patient for venovenous (vv) extracorporeal membrane oxygenation (ecmo) (cv surgery) through the right femoral vein, re-wiring through a previous dialysis site.The wire was inserted without resistance initially, butresistance was noted during insertion and removal.Upon removal, the wire was found to be shredded and significantly damaged.Ultimately, this damaged the patient's venous system (external iliac and femoral vein), resulting in hemorrhagic shock that required massive transfusion and interventional radiology for management.
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.

• Brand Name: BIOMEDICUS MULTISTAGE FEMORAL VENOUS CANNULA
• 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: 22013931
• Report Number: 9612164-2025-02380
• Device Sequence Number: 20806453
• Product Code: DWF
• UDI-Device Identifier: 00763000242343
• UDI-Public: 00763000242343
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 05/13/2025

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 Expiration Date: 07/28/2025
• Device Model Number: 96880-019
• Device Catalogue Number: 96880-019
• Device Lot Number: 2021071285
• 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: 04/16/2025
• Initial Report FDA Received Date: 05/13/2025
• Date Device Manufactured: 07/28/2021
• 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
• Patient Sex: Unknown