MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER II XP CARDIAC ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

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

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 08/07/2023

Event Type  Injury  

Event Description

Following completion of a procedure, the patient experienced a drop in blood pressure that required treatment.The procedure used the bsc blazer 10mm ablation catheter and the mdt cryoablation balloon for pvi and pacing.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BLAZER II XP CARDIAC ABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 17789167
• MDR Text Key: 324064074
• Report Number: MW5146001
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1