MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. LASSO 2515; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number D134302

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: LASSO 2515
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 1
• Product Code: DRF
• 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

• Date FDA Received: 05/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: D134302
• Device Lot Number: 16044550L
• 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
• Patient Sequence Number: 1
• Treatment: OTHER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 99