MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMO COOL SMART TOUCH; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133601

Device Problem Insufficient Information (3190)

Patient Problem Pericardial Effusion (3271)

Event Date 05/16/2014

Event Type  No Answer Provided  

Event Description

During atrial fibrillation ablation, steam pop sound was heard during radio frequency application.The patient subsequently developed a pericardial effusion, which required additional medical intervention and hospitalization.The physician/staff involved in the procedure do not know what caused the problem.All are experienced in this type of procedure and with this equipment.

• Brand Name: THERMO COOL SMART TOUCH
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 3333 diamond canyon rd; diamond bar CA 91765
• MDR Report Key: 3873884
• MDR Text Key: 15363543
• Report Number: 3873884
• Device Sequence Number: 2
• Product Code: LPB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/27/2014
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Invalid Data
• Device Catalogue Number: D133601
• Device Lot Number: 16039593MA
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2014
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/27/2014
• Patient Sequence Number: 1
• Treatment: OTHER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 99