MAUDE Adverse Event Report: MEDTRONIC CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number MEDTRONIC CRYO

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

During a pulse field ablation procedure to treat atrial fibrillation (afib), a farastar ablation generator was selected for use.It was reported that the stim connector had been pushed inside the console.They were unable to connect the cable without opening the console and retrieving the connector.Procedure was completed using a non bsc product (medtronic cryo).No patient complications reported.Unknown if product is going to be returned.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17489893
• MDR Text Key: 320695468
• Report Number: MW5122411
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: MEDTRONIC CRYO
• Patient Sequence Number: 1