MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D132702
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	12/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.The event date is unknown.As a result, the 1st day of the month has been entered as the event date.Therefore, date of event was processed as (b)(6) 2019.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a male patient underwent a persistent atrial fibrillation ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and suffered an epicardial effusion requiring a pericardiocentesis.Biosense webster, inc.Does not recommend the use of its devices in the epicardial space.The adverse event was discovered during use of biosense webster, inc.Products.The procedure was not successfully completed.The issue was resolved.The patient¿s condition is fully recovered.The patient was hospitalized for one additional day.In the opinion of the physician, the event was procedure related.The transseptal was performed with brk needle (abbott).Prior to discovering the tamponade, ablation was performed.There was no evidence of a steam pop.The irrigation settings were standard for smart touch.Graph, dashboard, vector and visitag were used for force visualization.There were no error messages displayed by biosense webster, inc.Equipment.The visitag module was used with the ablation index parameters and force as an additional filter.Ablation index options were used for coloring.
Additional Manufacturer Narrative
Clarification was received on the event reported on(b)(6)2020.Epicardial effusion did not occur, it was pericardial effusion.The h6.Patient codes remains the same of ¿cardiac tamponade¿.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9576686
• Report Number: 2029046-2020-00044
• Device Sequence Number: 2936647
• Product Code: LPB
• UDI-Device Identifier: 10846835009170
• UDI-Public: 10846835009170
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

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 Model Number: D132702
• Device Catalogue Number: D132702
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; NON BWI-ABBOTT BRK NEEDLE
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention