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

Model Number D132705

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

Patient Problem Cardiac Arrest (1762)

Event Date 10/27/2022

Event Type  Death  

Event Description

It was reported that an unknown male patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter.The patient went had pulseless electrical activity (pea) requiring cpr.The patient later passed away.It was reported that the after ablation the patient was being stimulated and vt/vf was induced.The patient had pulseless electrical activity (cardiac arrest), cpr was started, and the patient stabilized and went to the icu.Halfway during the procedure, the workstation exited the study and the study had to be continued.Carto 34517 g4c-3007, and g4cp-2924 hardware serial number; software 7.1.80.33.The adverse event occurred on (b)(6) 2022.This adverse event was discovered during use of biosense webster products, near the end of the procedure.The physician¿s opinion on the cause of this adverse event is that it was due to patient condition.Intervention provided was cpr and anesthesia support.The patient outcome of the adverse event is death.The patient required extended hospitalization because of the adverse event, the patient stayed in cicu.Generator piu: 34517, g4c-3007, g4cp-2924, g4rc-2995.The date of death is unknown; either (b)(6) 2022 or (b)(6) 2022 in physician¿s opinion, the cause of death was the patient¿s previous health condition.Patient death did not occur in lab.No other information was provided.A thermocool® smarttouch® sf catheter was used.Graph, dashboard, vector, and visitag force visualization features were used.The visitag module was used, parameters for stability used were 2.5 mm, 3 sec, 25% of 3 g.No additional filter was used with the visitag.Fti color options were used prospectively.All deaths were bwi fda approved ¿ ce mark devices are involved are reportable.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 15841716
• MDR Text Key: 304095232
• Report Number: 2029046-2022-02905
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• 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
• Treatment: CARTO 3 SYSTEM; CARTO VISITAG MODULE; SMARTABLATE GENERATOR
• Patient Outcome(s): Hospitalization; Life Threatening; Death; Required Intervention
• Patient Sex: Male