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

Catalog Number	BNI35BBH
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	09/21/2018
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.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Concomitant products: carto 3 external ref patch 6 pack (model# crefp6, lot# ll016361).Webster 10 pole catheter (model# d610dr005rt, lot # unknown) ).Lasso nav eco catheter (model# d134901, lot# 30028901l).Cook transseptal needle (model# unknown, lot# unknown).St.Jude medical agilis 8.5fr (model# unknown, lot# unknown).St.Jude medical sl3 sheath (model# unknown, lot# unknown).(b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent a pulmonary vein isolation (pvi) ablation procedure with an thermocool® sf nav bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.During the procedure, pvi was successfully performed without any issues reported.As part as their normal process, a transthoracic echo (tee) was performed while the patient was on the table showing no issues.Praxbind was administered to reverse anti-coagulant (pradaxa).The patient was extubated and then moved to his bed.Post procedure, after 20-30 minutes in recovery, the patient was reported to be highly-hypotensive.Transthoracic echo was performed again, and cardiac tamponade was confirmed.The patient was transferred to intensive care unit (icu) where a pericardiocentesis was performed to remove the fluid from the pericardium.Pericardial drainage was not successful, and the patient required a thoracotomy.The patient condition improved and was reported to be in stable condition after surgery.Extended hospitalization of 4-5 days was required for monitoring.Patient¿s outcome is fully recovered with no residual effects.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related as the adverse event occurred is one of the risks of radio frequency cardiac ablation.There were no error messages observed on any bwi equipment during the procedure.Transseptal puncture was performed with a cook transseptal needle with the guidance of transesophageal echocardiograph (toe) and a st.Jude medical agilis 8.5fr and a st.Jude medical sl3 sheath.The generator was set to power control mode.The catheter irrigation was set at 15ml/min rate with 30-40 watts of power depending on ablation area (posterior wall, ridge, roof).Temperature cut off was set to 48 degrees celsius.Throughout the case, there were at least 40-50 rf applications.The patient received heparin anticoagulant during the procedure to maintain an activated clotting time (act) of >350 seconds.

• 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: 8003217
• Report Number: 2029046-2018-02203
• Device Sequence Number: 13525312
• Product Code: LPB
• UDI-Device Identifier: 10846835003130
• UDI-Public: 10846835003130
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 09/25/2018

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 Expiration Date: 02/26/2021
• Device Catalogue Number: BNI35BBH
• Device Lot Number: 30024471L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/24/2018
• 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: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR