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

Catalog Number M490007

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Fistula (1862)

Event Date 06/19/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent atrial fibrillation ablation procedure that included thermocool smarttouch sf catheter.The patient experienced an esophageal fistula that required surgical intervention.Timing of adverse event: post use of bwi products, approximately 2 days after the procedure.Description of health hazard: it was reported that the patient had an adverse event post-procedure last month.The patient suffered an esophageal- pericardial fistula, approximately 2 days after the procedure.The physician said that it was possibly a perforation from the temperature probe in use, but cannot be sure.There was air getting trapped in the pericardium, causing discomfort for the patient two days after the procedure.The patient was admitted to the hospital (early july), then transferred to another hospital at some point, where an esophageal stent was placed.The patient had a prior breast cancer diagnosis with significant radiation.The physician stated that the patient may be discharged today.Physician's opinion on the cause of the adverse event: may be due to a perforation of the esophagus that possibly could have happened from the temperature probe in use, but really doesn't know.No error messages observed on bwi equipment during the procedure.The caller reviewed the procedure maps and there was nothing to indicate any issue during the procedure, with first-pass isolation of the right and left pulmonary veins and posterior wall.Additional event information: no bwi product malfunction.Possibly from procedure or patient condition.Intervention provided: stent input at (b)(6) hospital.Outcome of the adverse event: improved.Patient required extended hospitalization because of adverse event, at (b)(6) hospital for several days.Generator parameters (power or temperature control mode) and thresholds (temperature cut off and power cut off): power control.Temperature, impedance, and power at the time of the perforation: unknown perforation was diagnosed days later.Modalities used to prevent esophageal injury: circa temp probe.Esophageal injury confirmed at (b)(6) hospital.Not sure of specific test.Correct catheter settings were selected on the generator.Pump was switching from "low" to "high" flow during ablation.Carto 3 system did not indicate to re-zero the catheter.Force visualization used: graph, dashboard, vector, visitag.Parameters for stability with visitag module: 3 sec, 3 mm.Additional filter used with the visitag: respiration adjustment.Color options used: visitag surpoint.Generator information: smartablate serial number.(b)(6).Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.

Manufacturer Narrative

Biosense webster manufacturer's reference number (b)(4) has 2 reports.The stsf report is in manufacturer report number 2029046-2023-01746.The hardware investigation has begun but it has not been completed at this time.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.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 CA D-791 11; GM D-79111
• MDR Report Key: 17511986
• MDR Text Key: 320912035
• Report Number: 2029046-2023-50013
• 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: 07/21/2023,09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• 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: 07/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female