MAUDE Adverse Event Report: MEDTRONIC, INC. FREEZOR XTRA CARDIAC CRYOABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Heart Block (4444)

Event Date 06/01/2023

Event Type  Injury  

Event Description

It was reported that a right bundle branch block occurred.Timing was during cryoablation with freezer xtra (medtronic).The cryoablation was stopped immediately, and the patient left the room with the right bundle branch block.The procedure was a paroxysmal supraventricular tachycardia.Biosense webster complaint number (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: FREEZOR XTRA CARDIAC CRYOABLATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 17488115
• MDR Text Key: 320678135
• Report Number: MW5120838
• Device Sequence Number: 1
• Product Code: LPB
• 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: 06/28/2023

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/09/2023
• Patient Sequence Number: 1