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

Catalog Number	BNI35FJCT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	10/08/2018
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a female patient underwent an ablation procedure for idiopathic ventricular tachycardia (idvt) with a thermocool® sf nav bi-directional catheter and suffered cardiac tamponade requiring pericardiocentesis.During mapping phase, cardiac tamponade was discovered by ultrasound and confirmed by intracardiac echo (ice).Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardium.The patient was reported to be in stable condition after pericardial drainage.The patient was transferred to the intensive care unit (icu) and remained there one week after the procedure.Patient¿s outcome is improved.Retrograde approach to the left ventricle was cited as a factor that might have contributed to the adverse event.There¿s no information regarding physician¿s causality opinion.There were no error messages observed on any bwi equipment during the procedure.Transseptal puncture was not performed.The generator was set under thermocool® sf nav bi-directional catheter default settings at 30 watts and 60 seconds.Ablation did not occur prior to the adverse event.The catheter irrigation was set at 8-15ml/min and 2ml/min in low flow.The patient received anticoagulant (unspecified) during the procedure with an activated clotting time (act) at 300-350 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: 8033138
• Report Number: 2029046-2018-02238
• Device Sequence Number: 1263152
• Product Code: LPB
• UDI-Device Identifier: 10846835003260
• UDI-Public: 10846835003260
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/08/2018

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: BNI35FJCT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2018
• Initial Report FDA Received Date: 11/02/2018
• 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