MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Fistula (1862)

Event Date 08/07/2023

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.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 on (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.Manufacturer's reference number: (b)(4) during an internal review on (b)(6) 2023, noted a correction to the 3500a initial as 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:.".

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17750258
• MDR Text Key: 323470904
• Report Number: 2029046-2023-02077
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

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: D134804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/14/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GENERATOR KIT-US.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention