MAUDE Adverse Event Report: STOCKERT GMBH SMARTABLATE¿ SYSTEM RF GENERATOR (US); CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number M490007

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

Patient Problem Fistula (1862)

Event Date 06/23/2023

Event Type  Death  

Manufacturer Narrative

Per the reported event stating, ¿died on an unknown date, either (b)(6) 2023, or (b)(6) 2023, due to a suspected esophageal fistula,¿ processed ¿b2.Date of death¿ field as the earliest date provided of (b)(6) 2023.The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.Biosense webster inc.'s reference number (b)(4), has two reports: (1) manufacture report number # 2029046-2023-01834, for product code d134805, (thermocool® smart touch® sf bi-directional navigation catheter) (2) product code m490007, (smartablate¿ system rf generator (us).

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 (b)(6) 2023, that a patient who had an atrial fibrillation ablation procedure performed on (b)(6) 2023, died on an unknown date, either (b)(6) 2023 or (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, 3seconds.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

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.The investigation was completed on 05-oct-2023.Service was declined.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of biosense webster's quality process.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: SMARTABLATE¿ SYSTEM RF GENERATOR (US)
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 31; freiburg, b-w D-791 11; GM D-79111
• MDR Report Key: 17600444
• MDR Text Key: 321711078
• Report Number: 2029046-2023-50014
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2023,10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: M490007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/05/2023
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM.; SMARTABLATE PUMP KIT-US.; THMCL SMTCH SF BID, TC, D-F.
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Sex: Female