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

Catalog Number UNK_SMARTABLATE GENERATOR

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Fistula (1862)

Event Type  Injury  

Manufacturer Narrative

F14.Manufacturer postal code: d-79111.Multiple attempts have been made to obtain clarification on which system was used during this procedure.However, no further information has been made available.Since there is no clarification, no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding clarification of the system used in this event, a supplemental 3500a report will be submitted to the fda.Since no serial number was provided, no manufacturer record evaluation could be performed.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.Manufacturer's reference number: (b)(4).Biosense webster manufacturer's reference number (b)(4) has 2 reports.(1) manufacture report number # 2029046-2024-00670 for unknown thermocool smarttouch).(2) importer report number # 2029046-2024-50001 for the unknown ¿ system rf generator (us).

Event Description

It was reported a patient underwent a cardiac ablation procedure and patient experienced esophageal fistula.No further details were provided regarding the incident.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This report is for the smartablate generator.A separate report will be submitted for the unspecified thermocool smarttouch catheter.

Manufacturer Narrative

On 1-mar-2024, the product investigation was completed in the absence of information and a service request/work order for the complaint device.A service work order information for the unk_smartablate generator and asset information were not received.No further analysis could be performed and no additional information was obtained at this time.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
• 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: 18822903
• MDR Text Key: 336734565
• Report Number: 2029046-2024-50001
• Device Sequence Number: 1
• Product Code: LPB
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMARTABLATE GENERATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/01/2024
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM
• Patient Outcome(s): Life Threatening