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); Tachycardia (2095)

Event Date 04/25/2022

Event Type  Death  

Event Description

It was reported that a 62-year-old male patient (177 lbs.) underwent a left ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered ventricular fibrillation, cardiac arrest requiring cpr ultimately resulting in death.It was reported that the patient died during the case.They mapped the sinus rhythm to look at the scar with a pentaray catheter.After mapping for voltage, they took the pentaray catheter out of the patient and then put in the smart touch surround flow (stsf) catheter (df curve) and did some ablation for scar modification along the "border zone." at this time the patient went into a slow ventricular tachycardia at 100 beats per minute, and they mapped that using the smart touch surround flow ablation catheter.The medical team reported that it was during this time that the patient then went into ventricular fibrillation (v-fib) and cardiac arrest.The code team (interventional cardiology team) was called.Before the code team arrived, the electrophysiology (ep) lab team did manual compressions and shocked the heart out of v-fib and into normal sinus rhythm, however after the code team arrived the patient went into v-fib again.The patient was then shocked out of v-fib back to normal sinus rhythm but again only for a short time.The patient was shocked out of v-fib "several more times" before then going into a pulseless v-fib.Over the course of this intervention, the patient was given epinephrine and amiodarone, but was unsure if there was anything else given.While the code team was still treating the patient, the patient passed away.The time of death was recorded to be 16:48.In physician¿s opinion the patients cause of death was the vt leading to pulmonary edema and cardiac arrest.This adverse event discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it was patient condition.Relevant tests and labs don¿t during the code.Other relevant history includes cad, ischemic cardiomyopathy, ef 20%, icd for vt.A stockert gmbh smart ablate system with serial number (b)(4) was used.This case was not part of a clinical study.The bwi instruments used during the case were the pentaray catheter and the smart touch surround flow ablation catheter.The ablation catheter is not available to be returned.All deaths where 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.A manufacturing record evaluation was performed for the finished device number 30663698l and no internal action related to the complaint was found during the review.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® 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14465515
• MDR Text Key: 292342249
• Report Number: 2029046-2022-01086
• 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
• Report Date: 05/20/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/18/2022
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30663698L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2022
• Initial Date FDA Received: 05/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• 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: PENTARAY CATHETER; SMARTABLATE GENERATOR
• Patient Outcome(s): Death; Required Intervention; Life Threatening
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 80 KG