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

Model Number D132705

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 03/27/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with thermocool® smart touch® bi-directional catheter.The patient experienced a cardiac perforation.This incident is due to the fact that a spill occurred during the procedure, so the procedure could not be completed.It is not known exactly when the "perforation" of the myocardial tissue occurred.It was detected at the beginning of the ablation phase, when the patient developed atrial tachycardia and her blood pressure dropped; then the medical team proceeded to perform an echo and saw the spill.They waited until it was sealed since they saw that this effusion was small, and after waiting for a period of prudence and seeing the positive evolution of the patient, they continued with the case until they saw a certain effusion again and decided to finally cancel it.Only the left pulmonary veins were isolated.A total of 23 applications were made; all with normal impedance values.Some had high contact values, but they lasted a few seconds (respecting the recommended ablation index for the left atrium, 400 posteriorly and 500 anteriorly).Impedance rises were not detected in any application.The patient has not suffered consequences due to this incident.Other medical intervention was required for the spill, which was finally sealed.The event date originally provided was unknown.Additional information was received.The adverse event occurred on (b)(6) 2023.It was discovered during use of biosense webster products.Physician¿s opinion on the cause of this adverse event was that it was procedure related.Intervention provided was a carto ablation of atrial fibrillation.Outcome of the adverse event was fully recovered (no residual effects).Patient required extended hospitalization because of the adverse event as they had to control and check the patient was okay.Transseptal puncture was performed, needle details unknown.Prior to noting the adverse event, ablation was performed.No evidence of a steam pop.Irrigated catheter was used in the event, the flow setting was 2 and 30 ml/min.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.No error messages observed on biosense webster equipment during the procedure.Visitag module was used, parameters for stability used was tag index, tag size 3.Additional filter used with the visitag was respiration adjustment.

Manufacturer Narrative

The event date originally provided was unknown and the alert date of (b)(6) 2023.Additional information was received stating that the adverse event occurred on (b)(6) 2023.Therefore, clarification is being requested on the date discrepancy of event date (b)(6) 2023, but the alert date was reported as (b)(6) 2023.E1.Initial reporter phone: (b)(6).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 number lot 30899321m and no internal action related to the complaint was found during the review.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.Manufacturer's reference number:(b)(4).

Manufacturer Narrative

In the 3500a initial, it was reported, ¿the event date originally provided was unknown and the alert date of 24-mar-2023.Additional information was received stating that the adverse event occurred on 27-mar-2023.Therefore, clarification is being requested on the date discrepancy of event date 27-mar-2023, but the alert date was reported as 24-mar-2023.¿ additional information was received on 06-may-2023 clarifying that the correct alert date was 27-mar-2023.Therefore, the g3.Date received by manufacturer field for the 3500a initial which was processed as 24-mar-2023, should have been processed as 27-mar-2023.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 16771023
• MDR Text Key: 313598090
• Report Number: 2029046-2023-00852
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030031/S053
• 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: 06/02/2023

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 Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30899321M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/19/2023
• Supplement Dates Manufacturer Received: 05/06/2023
• Supplement Dates FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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: 71CM TRANSSEPTAL NEEDLE; 8.5F SHEATH WITH CURVE VIZ MDC; CARTO 3 SYSTEM; CARTO3 EXTERNAL REFPATCH 6PACK; PENTARAY NAV ECO 7FR, F, 2-6-2; TRNSPTL FXD SHEATH,63CM,ML0; UNKNOWN BRAND GENERATOR; UNKNOWN BRAND PUMP
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Female