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 08/06/2023

Event Type  Death  

Event Description

It was reported that a patient underwent an atrial fibrillation (af) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ system rf generator (us) and the patient experienced myocardial infarction requiring coronary stenting, cardiac tamponade, cardiac arrest and esophageal fistula and death.A few days after an afib case, there was a patient death.The patient went into the hospital having what was suspected to be a heart attack, they stented his left anterior descending artery (lad) and the patient went into cardiac arrest.They did a pericardiocentesis and an unknown amount of fluid was removed.This was all reported by the hospital staff which had ¿heard¿ of what happened but were not present during the event.The physician later stated the cause of death was related to an atrial esophageal fistula caused by an af ablation procedure.He stated this is a procedural complication but no autopsy was performed on the patient.

Manufacturer Narrative

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 # 2029046-2023-02035 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).(2) product code m490007 (smartablate¿ system rf generator (us)).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (af) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ system rf generator (us) and the patient experienced myocardial infarction requiring coronary stenting, cardiac tamponade, cardiac arrest and esophageal fistula and death.A few days after an afib case, there was a patient death.The patient went into the hospital having what was suspected to be a heart attack, they stented his left anterior descending artery (lad) and the patient went into cardiac arrest.They did a pericardiocentesis and an unknown amount of fluid was removed.This was all reported by the hospital staff which had ¿heard¿ of what happened but were not present during the event.The physician later stated the cause of death was related to an atrial esophageal fistula caused by an af ablation procedure.He stated this is a procedural complication but no autopsy was performed on the patient.Device investigation details: follow-up was performed since the device was not shipped for service or repair.Response was received indicating service was being declined by the customer as no service is needed.As such, the device investigation has been completed which included a device history record (dhr) review.The dhr 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 ref#: (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: 17712767
• MDR Text Key: 322987572
• Report Number: 2029046-2023-50015
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2023,09/08/2023

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: M490007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM.; THMCL SMTCH SF BID, TC, D-F.
• Patient Outcome(s): Required Intervention; Death