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 08/07/2023

Event Type  Injury  

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 # 2029046-2023-02077 for product code d134804 (thermocool® smart touch® sf bi-directional navigation catheter); (2) importer report number # 2029046-2023-50016 product code m490007 (smartablate¿ system rf generator (us)).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure that included thermocool® smart touch® sf bi-directional navigation catheter and smartablate¿ system rf generator (us).The patient experienced esophageal fistula that required surgical intervention.Patient was treated on (b)(6) 2023 and was in surgery (b)(6) 2023 for an esophageal fistula that was found.The patient was in stable condition at that time.The generator had been used for several other successful procedures since the case on (b)(6) 2023.Additional information was received.The physician did not provide a causality opinion for the cause of this adverse event.Patient required extended hospitalization, they were readmitted for this as it was approximately two weeks post procedure.Account is not requesting service of the generator at this time (generator has been used for dozens of cases since).The adverse event was assessed as mdr reportable under both the thermocool® smart touch® sf bi-directional navigation catheter and smartablate¿ system rf generator (us).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Importer reference number: (b)(4) during an internal review on 15-sep-2023, noted the following corrections to the 3500a initial: in h10.Additional manufacturer narrative reported, ¿biosense webster inc.'s reference number (b)(4) has two reports:¿ and it should have stated, ¿biosense webster inc.'s reference number (b)(4) has two reports:." in f14.Manufacturer address street line 1 reported, ¿boetzinger strasse 72¿ and it should have been processed as ¿boetzinger strasse 31¿.H6.Type of investigation was blank and it should have been processed to "type of investigation not yet determined (b21)".Investigation finding was blank and it should have been processed to "results pending completion of investigation (c21).Investigation conclusions was blank and it should have been processed to "conclusion not yet available (d16)".

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure that included the smartablate¿ system rf generator (us).The patient experienced esophageal fistula that required surgical intervention.The investigation was completed on 30-oct-2023.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.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.Importer 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 D-791 11; GM D-79111
• MDR Report Key: 17751061
• MDR Text Key: 323469821
• Report Number: 2029046-2023-50016
• 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,Followup
• Report Date: 08/24/2023,11/17/2023

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?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/30/2023
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/15/2023; 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THMCL SMTCH SF BID, TC, F-J
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization