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 Problem Fistula (1862)

Event Date 06/19/2023

Event Type  Injury  

Manufacturer Narrative

Biosense webster manufacturer's reference number pc (b)(4) has 2 reports.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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.Manufacturer's reference number: pc (b)(4).

Event Description

It was reported that a patient underwent atrial fibrillation ablation procedure that included thermocool smarttouch sf catheter.The patient experienced an esophageal fistula that required surgical intervention.Timing of adverse event: post use of bwi products, approximately 2 days after the procedure.Description of health hazard: it was reported by the caller that the patient had an adverse event post-procedure last month.The physician informed the caller today.The patient suffered an esophageal- pericardial fistula, approximately 2 days after the procedure.The physician said that it was possibly a perforation from the temperature probe in use, but cannot be sure.There was air getting trapped in the pericardium, causing discomfort for the patient two days after the procedure.The patient was admitted to the hospital (b)(6) , then transferred to another hospital at some point, where an esophageal stent was placed.The patient had a prior breast cancer diagnosis with significant radiation.The physician stated that the patient may be discharged today.Physician's opinion on the cause of the adverse event: may be due to a perforation of the esophagus that possibly could have happened from the temperature probe in use, but really doesn't know.No error messages observed on bwi equipment during the procedure.The caller reviewed the procedure maps and there was nothing to indicate any issue during the procedure, with first-pass isolation of the right and left pulmonary veins and posterior wall.Additional event information: no bwi product malfunction., possibly from procedure or patient condition.Intervention provided: stent input at (b)(6) hospital.Outcome of the adverse event: improved.Patient required extended hospitalization because of adverse event, at (b)(6) hospital for several days.Generator parameters (power or temperature control mode) and thresholds (temperature cut off and power cut off): power control.Temperature, impedance, and power at the time of the perforation: unknown perforation was diagnosed days later.Modalities used to prevent esophageal injury: circa temp probe.Esophageal injury confirmed at cone hospital.Not sure of specific test.Correct catheter settings were selected on the generator.Pump was switching from "low" to "high" flow during ablation.Carto 3 system did not indicate to re-zero the catheter.Force visualization used: graph, dashboard, vector, visitag.Parameters for stability with visitag module: 3 sec, 3 mm.Additional filter used with the visitag: respiration adjustment.Color options used: visitag surpoint.Generator information: smartablate serial number.G4c-0709 since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.

• 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: 17504160
• MDR Text Key: 321042055
• Report Number: 2029046-2023-01746
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• 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: CARTO 3 SYSTEM; CARTO VISITAG MODULE; UNSPECIFIED PUMP
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Female