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

Model Number D134805

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

Patient Problems Cardiac Arrest (1762); Tachycardia (2095); Ventricular Fibrillation (2130)

Event Date 03/29/2023

Event Type  Death  

Event Description

It was reported that a patient underwent a isvt ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac arrest, ventricular tachycardia (vt) and ventricular fibrillation (vf) and ultimately passed away.It was reported that after a vt case had completed, it was noticed that the patient went into cardiac arrest, and expired.They reported that the patient went into vt and then vf a few times during the procedure, which the anesthesiologist noticed on the anesthesia monitor.Patient was then "shocked" out of it and stable paced rhythm was restored.The procedure was then called and completed.After the catheters were removed from the body, and they were closing the groin, the anesthesiologist then noticed on the anesthesia monitor that the patient had gone into vt again.They performed acls protocol.The patient was coded for about 20-25 minutes, before they called it and the patient expired.The following bwi devices were also in use: webster® quadrapolar deflectable catheter (catheter information unknown) striker reprocessed acunav catheter (catheter information unknown) the date of death was (b)(6) 2023.Devices not available for return.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® 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: 16817306
• MDR Text Key: 314031375
• Report Number: 2029046-2023-00899
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2023
• 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
• Treatment: STRIKER REPROCESSED ACUNAV CATHETER; WEBSTER® QUADRAPOLAR DEFLECTABLE CATHETER
• Patient Outcome(s): Death; Life Threatening; Required Intervention