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

Model Number	M490007
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	12/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The stsf report is in manufacturer report number 2029046-2023-00384.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a smartablate¿ system rf generator (us).The patient suffered an esophageal injury.It was reported that after an atrial fibrillation case had completed on (b)(6), 2022, that patient returned to the hospital on (b)(6), 2022, and it was noticed that the patient had an "esophageal injury." they reported that the patient was then hospitalized.They believe that the patient is in stable condition, but they could not confirm the information.They do not have any other event details available at the time of the call.They are declining smartablate generator service at this time.They are requesting documentation only.Dispatch was approved by (b)(6).The lot number of the catheter is unknown.The adverse event was discovered after use of biosense webster products.Physician¿s opinion on the cause of this adverse event was the procedure.Intervention provided was unknown.Outcome of the adverse event was unknown.Patient required extended hospitalization because of the adverse event due to the esophageal injury.Relevant tests/laboratory data-unknown.Generator information is a g4c-0088i.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 and mdr-reportable.Two reports exist for this event: this report is for the smartablate generator.Another report was submitted for the stsf.

• Brand Name: SMARTABLATE¿ SYSTEM RF GENERATOR (US)
• Common Device Name: 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: 16439940
• Report Number: 2029046-2023-50004
• Device Sequence Number: 7325453
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2023

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
• Operator of Device: Health Professional
• Device Model Number: M490007
• 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: 01/27/2023
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Female