MAUDE Adverse Event Report: MEDTRONIC, INC. ARCTIC FRONT ADVANCE PRO¿; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number AFAPRO28

Patient Problem Insufficient Information (4580)

Event Date 06/06/2023

Event Type  malfunction  

Event Description

Arctic front advance pro cath was inserted into the pulmonary vein but the coaxial umbilical frosted on the outside.Arctic fron cath was removed.The arctic front cath was replaced with new one.No other issues noted.

• Brand Name: ARCTIC FRONT ADVANCE PRO¿
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne mounds view; mounds view MN 55112
• MDR Report Key: 17497254
• MDR Text Key: 320768222
• Report Number: 17497254
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: AFAPRO28
• Device Lot Number: 07356
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2023
• Date Report to Manufacturer: 08/10/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA