MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CARTO; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Device Problem Insufficient Information (3190)

Patient Problem Nerve Damage (1979)

Event Date 04/07/2023

Event Type  Injury  

Event Description

Situation: pvi was performed with polarx made by bostonscientific (concomitant with carto).Temporary phrenic nerve injury was observed during balloon isolation of the right pv.Timing: 2 hours after the start of carto use.How to complete the procedure: balloon ablation was stopped, and it was switched to rf catheter ablation procedure with smart touch sf catheter for pvi.The procedure was completed without any problems.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CARTO
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 17488568
• MDR Text Key: 320689795
• Report Number: MW5121267
• Device Sequence Number: 1
• Product Code: DQK
• 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: 05/04/2023

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