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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/16/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a cardiac tamponde which required surgical intervention and prolonged hospitalization.In a ventricular procedure, the patient's blood pressure decreased during conducting 8th ablation of right ventricle, resulting in drainage of effusion.Cardiac tamponade occurred.The procedure was terminated because thoracotomy with surgical intervention was performed.On that day, bleeding stopped, and the condition of the patient was stable.The physician's opinions on the relationship between the event and the product was that this was a case of epicardial ablation.Because bleeding from the puncture site as a result of thoracotomy, the event was unrelated to ablation and the carto 3 system.There were no abnormalities observed prior to and during use of the product.Additional information was received 28-nov-2022.Physician¿s opinion on the cause of this adverse event was that it was procedure related.The physician commented that the cause of this issue was puncture from epi because the bleeding occurred from the puncture site.The outcome of the adverse event was improved.Patient required extended hospitalization because of the adverse event.No transseptal puncture performed.No pop was reported.No error was observed.Additional information was received on 07-dec-2022.The patient was recovered uneventfully and discharged from the hospital without any sequelae.

Manufacturer Narrative

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 30863225l number, and no internal actions 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

Additional information was received on 23-dec-2022.Other relevant history was funnel chest.The flow setting for the irrigated catheter was 30w 8ml/min.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.Force visualization features used were vector and dashboard.Parameters for stability for the visitag module used was 3mm 3sec 25% tag2mm.Color options used prospectively was 400-450.Therefore, d10.Concomitant medical products and therapy dates was updated.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® 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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15992405
• MDR Text Key: 305582569
• Report Number: 2029046-2022-03139
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30863225L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• 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: SMARTABLATE GEN. KIT (JAPAN); UNKNOWN BRAND PUMP; UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening