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

Model Number	BNI35FJCT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device investigation details: information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number (b)(4) and no internal actions related to the complaint was found during the review.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a 55-year-old male patient born on (b)(6) 1947, underwent a left ischemic ventricular tachycardia (isvt - left) ablation procedure with a thermocool® sf nav bi-directional catheter and the patient suffered cardiac tamponade requiring pericardiocentesis, surgical intervention and prolonged hospitalization.It was reported that the patient suffered a pericardial effusion.Towards the end of the case the patients¿ blood pressure dropped.The intracardiac echocardiography (ice) catheter was used to confirm a pericardial effusion.A pericardiocentesis was performed and about 2 liters of fluid was removed from the pericardial space and transfused back into the patient.The patient stabilized for a time, but the pressure dropped again.The patient was taken to the operating room (or).Caller stated that a max of 30 watts was used during the procedure and total ablation time was 20 min 16 seconds.Catheter irrigation was run per the catheter instruction for use (ifu) guidelines.No further information was available at the time of the call.Additional information received indicated the bwi representative consultant didn¿t get the physician opinion post procedure since the doctor went to the surgery room with patient.They waited for 2 hours after the patient was wheeled out from the ep procedure room, and physician didn¿t come back.The next day the bwi representative was informed by staff that the patient had open heart surgery to repair the effusion and was slowly recovering.The patient required extended hospitalization because of the adverse event.The patient had stayed almost a week after open heart surgery.Other relevant history includes implantable cardioverter defibrillators (icd) device to prevent vt.A smartablate generator was used in the event.No transeptal was done during the procedure.No steam pop was heard during the procedure.An irrigated catheter was used in the event.The default flow setting was use during the procedure.Correct catheter settings were selected on the smartablate generator for the procedure.The communication between the pump and ablation system was working and correct irrigation was delivered during the procedure.No error messages were seen during the procedure.

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15480705
• Report Number: 2029046-2022-02305
• Device Sequence Number: 14857976
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2025
• Device Model Number: BNI35FJCT
• Device Catalogue Number: BNI35FJCT
• Device Lot Number: 30729149L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SMARTABLATE GENERATOR KIT-US; UNKNOWN ICE CATHETER; UNKNOWN PUMP
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male