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); Perforation of Vessels (2135)

Event Date 02/27/2023

Event Type  Death  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30961042l number, and no internal action related to the complaint was found during the review.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).

Event Description

It was reported that a patient underwent a idvt ¿ left ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a vessel perforation and cardiac arrest and ultimately passed away.It was reported that during a left heart catheterization idvt ablation, after rf (radiofrequency) applications, the patient had st depressions on the recording system and the carto 3 system monitor.The patient became unstable with st elevations and runs of vt (ventricular tachycardia) and a left heart catheterization was performed.They reported that there was an injury to the left vein.During the left heart catheterization, it was seen there was injury to the left main artery.A stent was deployed in the lad and left circumflex artery.The patient continued to degenerate with episodes of vf (ventricular fibrillation).Several cardioversions and cpr were performed.Cardio thoracic surgeon arrived and the patient went on ecmo.The patient was in a stable condition when they left the ep lab.The catheter is not available for return.There was injury to the left main artery.The event was discovered with a left heart catheter, st depressions on the recording system and runs of vt.A stent was deployed in the lad and circumflex artery, and the patient went on echo.Patient is now stable.It was confirmed through a left heart catheterization.The physician¿s opinion of this adverse event was that it was caused by ablating in close proximity to the left main artery.Outcome of the adverse event was death.The patient died in the icu several hours later, on the same day.Other relevant history- this was a redo procedure for this patient as they had a reoccurrence of a previously ablated idiopathic pvc.Generator information was a - smartablate system rf generator, ref m490002, sn (b)(4).All deaths were bwi.Fda approved ¿ ce mark devices are involved are reportable.

• 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: 16616955
• MDR Text Key: 312004190
• Report Number: 2029046-2023-00639
• 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: Physician
• Type of Report: Initial
• Report Date: 03/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2023
• 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
• Device Lot Number: 30961042L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/15/2022
• 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; SMARTABLATE SYSTEM RF GENERATOR
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization; Death
• Patient Age: 58 YR
• Patient Sex: Female