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

Model Number D134804

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Respiratory Failure (2484)

Event Date 04/26/2023

Event Type  Death  

Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced respiratory failure and cardiac arrest requiring resuscitation but ultimately passed away.After the vt ablation, the patient passed away in route to the critical care unit (ccu).Toward the end of the ablation in the left ventricle, the patient's blood pressure decreased.The physician stopped the case, and when the patient was extubated, it was noted that they were not breathing on their own.They started ventilating the patient, but when that was not working, they administered cardiopulmonary resuscitation (cpr).This continued for several minutes before rushing the patient to the cardiac care unit.On the way to the ccu the patient expired.The death occurred on (b)(6) 2023, the caller was made aware (b)(6) 2023.The physician did not indicate that they believed bwi equipment contributed to the patient event.The caller stated the patient was sick pre-procedure, had lung cancer.Additional information was received.Physician¿s opinion on the cause of this adverse event was the patient condition.Other relevant history-- patient had a history of lung cancer.In physician¿s opinion, the cause of death was respiratory failure.

Manufacturer Narrative

Additional clarification was requested on the alert date as alert date in the product complaint is (b)(6) 2023; however, in the event description it reflects as (b)(6) 2023.However, no further information has been made available.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Additional 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.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

In the 3500a initial it was reported that additional clarification was requested on the alert date as alert date in the product complaint was 26-apr-2023; however, in the event description it reflected as 27-apr-2023.However, no further information had been made available.Clarification was received on 25-may-2023 that the correct alert date is 27-apr-2023.Therefore, g3.Date received by manufacturer field in the 3500a initial should have been 27-apr-2023.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 24-may-2023, noted a correction to the 3500a initial as in error omitted the physician information.Therefore, added in section e.Initial reporter the physician information.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16996557
• MDR Text Key: 315879437
• Report Number: 2029046-2023-01140
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death