MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC BIO-MEDICUS FEMORAL ARTERY CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number CB96570-021

Device Problems Failure to Advance (2524); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2023

Event Type  malfunction  

Event Description

Surgeon was unable to advance an extracorporeal membrane oxygenation (ecmo) cannula into the femoral artery during a case this morning.There was a small bulged area on the distal end of the cannula.This small defect prevented the cannula from fitting in the femoral artery.A second cannula was opened and was free from defect, and advanced into the artery without incident.

• Brand Name: MEDTRONIC BIO-MEDICUS FEMORAL ARTERY CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 17049354
• MDR Text Key: 316402333
• Report Number: 17049354
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/25/2023

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
• Device Operator: Health Professional
• Device Model Number: CB96570-021
• Device Catalogue Number: CB96570-021
• Device Lot Number: 222642160
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/25/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA