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

Catalog Number	BNI35BDCT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); No Code Available (3191)
Date of Event	03/27/2019
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturing record evaluation cannot be conducted because no lot number was provided by the customer.(b)(4).
Event or Problem Description
It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® sf nav bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.Post-procedure (approximately 20-30 minutes), the patient complained about chest pain.Cardiac tamponade was confirmed by echo.Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardium.The patient was transferred to the operating room where patient¿s chest was opened, and stitches were placed to repair the perforation.Extended hospitalization was required as a result of the event.Patient¿s outcome is improved.The physician did not provide a causality opinion.Transseptal puncture was performed with a brk-1 transseptal needle.Two sl-1 sheaths were used during the case.The generator was used with default settings in power control mode.The physician ablated 35 watts on ridge/anterior wall and 25 watts on posterior wall.The catheter irrigation was used with default settings.No error messages were observed on any bwi equipment during the procedure.
Additional Manufacturer Narrative
During an internal review on (b)(6)2019 , it was noted that ¿ manufacturer address street line 1¿ on the 3500a initial report needed correction.It was initially submitted as ¿(b)(4)¿.The correct address is ¿(b)(4).¿.Therefore, ¿ manufacturer address street line 1¿ has been re-populated.Manufacturer's ref # (b)(4).

• Brand Name: THERMOCOOL® SF NAV 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: 8540741
• Report Number: 2029046-2019-03017
• Device Sequence Number: 360553
• Product Code: LPB
• UDI-Device Identifier: 10846835003147
• UDI-Public: 10846835003147
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2019

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 Catalogue Number: BNI35BDCT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 04/29/2019
• 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: Hospitalization; Life Threatening; Required Intervention