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

Catalog Number D134805

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

Patient Problem Fistula (1862)

Event Date 06/23/2023

Event Type  Death  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ system rf generator (us).The patient developed an esophageal fistula and ultimately passed away.Caller reported that they were notified on 25-jul-2023 that a patient who had an atrial fibrillation ablation procedure performed on (b)(6) 2023, died on an unknown date, either on (b)(6) 2023 due to a suspected esophageal fistula.The caller stated that the physician stated that the patient complained about gerd or heard burn and that is why they think it could be an esophageal fistula.The caller also stated that there was nothing they can think of during the procedure.The caller does not have any additional information regarding the procedure.Additional information was received.The adverse event occurred on (b)(6) 2023.It was discovered post use (ablation was on (b)(6) 2023).Physician¿s opinion on the cause of this adverse event was the procedure.Outcome of the adverse event was death.Visitag module was used, parameters for stability used was 3mm, 3 seconds.Additional filter used with the visitag was 3g, 25% fot.Color options used prospectively was other.In physician¿s opinion, the cause of death was an atrioesophageal fistula.Generator parameters was power control mode, 50w, 10 seconds.No error messages observed on biosense webster equipment during the procedure.Modalities used to prevent esophageal injury was anesthesia administered temperature.The esophageal injury was only suspected, doctor just learned of patient death.The carto® 3 system did not indicate to re-zero the catheter.

Manufacturer Narrative

Per the reported event stating, ¿died on an unknown date, either on (b)(6) 2023 due to a suspected esophageal fistula,¿ processed ¿b2.Date of death¿ field as the earliest date provided on (b)(6) 2023.The device has been reported as discarded, 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Biosense webster inc's reference number: (b)(4) has two reports: (1) manufacture report for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(2) importer report number#: 2029046-2023-50014, product code: m490007 (smartablate¿ system rf generator (us).

• 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: 17599693
• MDR Text Key: 321710548
• Report Number: 2029046-2023-01834
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2023

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 Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 08/22/2023
• 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: CARTO 3 SYSTEM.; SMARTABLATE GENERATOR KIT-US.; SMARTABLATE PUMP KIT-US.
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Sex: Female