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

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Fistula (1862)

Event Date 09/11/2023

Event Type  Injury  

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 31038132l number, and no internal action related to the complaint was found during the review.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.Note: the e1.Initial reporter facility name and additional details were not provided only the initial reporter name and phone as (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced esophageal fistula and stroke that required surgical intervention.The fistula was identified on (b)(6) 2023.The perforation was not noted at the time of surgery.The fistula is a clinical evolution that appeared weeks later.Magnetic resonance imaging (mri) was used to confirm the esophageal injury.The physician's opinion on the cause of the adverse event is that it was procedure related.Per physician: " there is no way to see an af in the same way because, regardless of technique or care, it is a reality that does not depend much on who does it.It's something inherent to the procedure.In other words, even if i improve my technique and take extra care, the risk is still there.¿rmt¿ and surgery was attempted to correct the fistula.The patient also developed a bilateral stroke and required prolonged hospitalization.No complaints about a bwi product malfunction.There were no error messages on bwi equipment.The smartablate generator parameters were power control, 30w.A transesophageal thermometer was used as a modality to prevent esophageal injury.

Manufacturer Narrative

On 28-nov-2023, additional information was received clarifying that intervention previously reported as ¿rmt¿ was incorrect and should have been ¿mri¿ (magnetic resonance imaging).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• 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: 18070035
• MDR Text Key: 327353761
• Report Number: 2029046-2023-02526
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31038132L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2023
• 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: CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-WW; TRANSESOPHAGEAL THERMOMETER
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Male