MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	BDI35DFRT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	03/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an accessory pathway ablation procedure with an ez steer¿ bi-directional electrophysiology catheter and thermocool® sf bi-directional catheter and suffered a cardiac tamponade.During the accessory pathway procedure, a cardiac tamponade was detected.There is no information regarding interventions, extended hospitalization, patient outcome, factors that may have contributed to the adverse event, or the physician¿s causality opinion.There were no errors reported on any biosense webster, inc.Products or equipment during the procedure.There is no information regarding transseptal puncture, sheath, generator parameters, generator settings, power titration, overall ablation time at the site of injury, last ablation cycle time at the site of injury, irrigated catheter flow rate, or anticoagulation during the procedure.This was not a carto system case, as the catheters were non-navigational.

• Brand Name: THERMOCOOL® SF BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7442337
• Report Number: 2029046-2018-01447
• Device Sequence Number: 19106176
• Product Code: LPB
• UDI-Device Identifier: 10846835002812
• UDI-Public: 10846835002812
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: BDI35DFRT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2018
• Initial Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening