MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BSC BLAZER 10MM ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

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.Disclaimer statement: this report reflects information received by fda in the form of a notification per 803.22 (b)(2).Ref report: mw5146000.

• Brand Name: BSC BLAZER 10MM ABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 17789026
• MDR Text Key: 324234682
• Report Number: MW5145999
• 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: Other
• 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