MAUDE Adverse Event Report: BOSTON SCIENTIFIC RHYTHMIA MAPPING SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Patient Problems Perforation (2001); Pericardial Effusion (3271)

Event Type  Injury  

Event Description

Following a successful cryo ablation procedure, a post-activation mapping procedure was performed with boston scientific¿s orion mapping catheter and rhythmia mapping system.The orion mapping catheter was inserted into the left appendage and subsequently the appendage was perforated.Following the post activation mapping procedure, a large effusion was seen forming under intracardiac echocardiography (ice).The patient underwent a pericardial tap, emergency surgery, and extended or prolonged hospitalization.This report reflects information received by fda in the form of a notification per 803.22 (b) (2).Ref report: mw5146773.

• Brand Name: RHYTHMIA MAPPING SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17911625
• MDR Text Key: 325577618
• Report Number: MW5146774
• Device Sequence Number: 1
• Product Code: DQK
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention