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

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

Patient Problem Fistula (1862)

Event Date 01/16/2024

Event Type  Death  

Manufacturer Narrative

D 4.Catalog: unk_smart touch unidirectional.It was indicated that the device is not available for return, 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 number # 2029046-2024-00790 for product code unk (thermocool® smart touch® sf uni-directional navigation catheter).(2) uf/importer report number # 2029046-2024-50002 product code m490007 (smartablate¿ system rf generator (us)).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) cardiac ablation, and the patient experienced an esophageal fistula that resulted in death.It was reported that an esophageal fistula was received from an emergency room (er) physician on a patient who had gone through an afib procedure on (b)(6) 2024.The physician stated that the patient came to the er on that date complaining of chest discomfort.The patient was sent for a computed tomography (ct) scan to evaluate the issue and passed away while having the ct scan done.There was no information regarding the ablation or diagnostic catheters nor has the information for the generator used for ablation.Additional information received indicated that the lot numbers of the devices are unknown as the event did not occur until weeks after the ablation.Therefore, all catheters and cables had been sent to reprocessing.Confirmation was received that a smartablate generator was used and the serial number was provided.The physician¿s opinion on the cause of death was atrio-esophageal (ae) fistula.It is unknown when in the procedure the fistula occurred as the physician and staff were very diligent and conservative when monitoring esophageal temperature during ablation of posterior wall.There was no device malfunction reported on bwi products.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 18877156
• MDR Text Key: 337352684
• Report Number: 2029046-2024-00790
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2024
• 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
• Patient Outcome(s): Life Threatening; Death