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 Stroke/CVA (1770); Fistula (1862)

Event Date 03/08/2023

Event Type  Death  

Manufacturer Narrative

The medical director information at (b)(6) was provided: (b)(6).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 # 2029046-2023-00988 for product code d134804 (thermocool® smart touch® sf bi-directional navigation catheter).(2) importer report number # 2029046-2023-50010 product code m490007 (smartablate¿ system rf generator (us)).Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal 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 cerebrovascular accident and ultimately passed away.It was reported that after completing the procedure on (b)(6) 2023, the patient was admitted to the intensive care unit (icu) with an atrial esophageal fistula.They stated that the information provided was limited.The patient expired on (b)(6) 2023.The patient was treated at another hospital.They stated being notified today of the event and the medical director is able to provide more information if needed.A request was sent to the caller for information on the smartablate¿ system rf generator (us), but the caller emailed back with a response from the medical director not being concerned with having the smartablate¿ system rf generator (us) evaluated since the generator has been involved in multiple cases in the time between the adverse event and now and they have not seen any other incidents.Additional information was received.The patient was admitted to another hospital several weeks post afib ablation for a possible cerebral ischemia/embolic event and subsequently was found to have an atrial esophageal fistula.Thermocool® smarttouch® sf catheter was used.They presumed standard settings for surpoint of 3mm 3sec was used for the visitag module.Additional filter used with the visitag was 3g 25%.Color options used prospectively was index.Standard power control mode: thresholds should be defaults; was used as the generator parameters.Perforation was not noted at the time of the procedure.No error messages observed on biosense webster equipment during the procedure.The physician routinely tracks esophageal temperature with a temperature probe in the esophagus which is tied to a quadrapolar catheter to allow for visualization on the carto system for proper placement.The esophageal injury was noticed several weeks post procedure when the patient was admitted to the hospital for a cerebral ischemia event.It is not uncommon to notice a re-zero message during any procedure of sufficient duration but since this injury was not noted during the case, they could not comment on whether or not the system indicated a need to re-zero related to the injury.The adverse event was discovered post use of biosense webster product.Outcome of the adverse event was death.

Manufacturer Narrative

The investigation was completed on 17-jun-2023.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 30954077l number, 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16903491
• MDR Text Key: 314926144
• Report Number: 2029046-2023-00988
• 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,Followup
• Report Date: 06/19/2023

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 Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30954077L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 06/17/2023
• Supplement Dates FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2022
• 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: SMARTABLATE GENERATOR KIT-US; UNK_CARTO 3
• Patient Outcome(s): Death; Hospitalization