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 04/22/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a ventricular tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade.The patient suffered cardiac tamponade and was making outpatient visits once a month.There is no further information about the hospitalization and if any additional intervention was performed.The physician's opinions on the relationship between the event and the product was that the event may have been caused by paracentesis for approach the epicardium during epicardial ablation.Physician¿s opinion on the cause of this adverse event is that it was procedure related.There were no abnormalities observed prior to and during use of the product.

Manufacturer Narrative

Device investigation details: information received indicates that the device is not available for return, 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 30712249l, and no internal actions 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(4).

Manufacturer Narrative

On 12-jan-2023, additional information was received indicating the adverse event was discovered during use of biosense webster products.The patient¿s outcome from the adverse event was reported as fully recovered.A smartablate generator was used with the correct catheter settings selected on the generator and the pump flow setting was normally controlled by the generator.No error messages observed on biosense webster equipment during the procedure.A transseptal puncture was not performed.No ablation was performed before noticing the pericardial effusion.No evidence of evidence of steam pop.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: 15968379
• MDR Text Key: 305335257
• Report Number: 2029046-2022-03094
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30712249L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• 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: 7FR DECAN,11P,D,2.4MMLE,282MM,; SOUNDSTAR ECO SMS 8F CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention