MAUDE Adverse Event Report: STOCKERT GMBH SMARTABLATE GENERATOR KIT-US; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	M490007
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
F14.Manufacturer postal code: d-79111.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 # 2029046-2023-02883 for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter) (2) importer report number # 2029046-2023-50019 product code m490007 (smartablate¿ system rf generator (us).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) cardiac ablation procedure which included the use of a thermocool® smart touch® sf bi-directional navigation catheter and smartablate¿ system rf generator, and experienced an esophageal fistula and received a surgical intervention.The only information provided was that the patient suffered an esophageal fistula after the procedure but could not confirm when it happened and any details on how the injury was discovered.Patient has improved.The catheter worked as expected with no issues during the procedure.Correct settings were utilized on devices and no errors messages on the equipment.An esophageal temperature monitoring single probe was used to prevent esophageal injury.The physician's opinion on the cause was that it was procedure related.
Additional Manufacturer Narrative
The investigation was completed on 26-dec-2023 for the smartablate generator.It was reported that a patient underwent an atrial fibrillation (afib) cardiac ablation procedure which included the use of a thermocool® smart touch® sf bi-directional navigation catheter and smartablate¿ system rf generator, and experienced an esophageal fistula and received a surgical intervention.The only information provided was that the patient suffered an esophageal fistula after the procedure but could not confirm when it happened and any details on how the injury was discovered.Patient has improved.The catheter worked as expected with no issues during the procedure.Correct settings were utilized on devices and no errors messages on the equipment.An esophageal temperature monitoring single probe was used to prevent esophageal injury.The physician's opinion on the cause was that it was procedure related.Investigation details for the smartablate generator: remote support confirmed the unit was performing as intended; therefore, no failure was found with the system.A device history record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.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).
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) on 22-jan-2024, it was noted that 3500a follow up report# (b)(4) was missing f6.Uf/importer event awareness date and f 8.User facility date of report.Therefore, these fields were updated on this report.

• Brand Name: SMARTABLATE GENERATOR KIT-US
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 31; freiburg, b-w D-791 11; GM D-79111
• MDR Report Key: 18292776
• Report Number: 2029046-2023-50019
• Device Sequence Number: 17833068
• Product Code: LPB
• UDI-Device Identifier: 04260166371390
• UDI-Public: 04260166371390
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2024
• Report Date (Section F): 11/11/2023

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 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: 12/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/08/2023
• Supplement Report FDA Received Date: 01/22/2024; 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THMCL SMTCH SF BID, TC, D-F.; UNK_CARTO 3.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown