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 Cardiac Tamponade (2226)

Event Date 02/29/2024

Event Type  Injury  

Event Description

It was reported a patient underwent an atrial fibrillation (afib) cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and patient experienced cardiac tamponade treated with a pericardiocentesis.During the procedure, appearance of pericardial effusion with poor hemodynamic parameters and the patient had to be drained.No difficulty during transseptal puncture or during radio frequency (rf) delivery.Physician had no idea of what happened.Delay of 20 minutes.Procedure successfully completed.Additional information was received.The adverse event was discovered during use of biosense webster, inc.Products at the end of the procedure.The physician¿s opinion on the cause of this adverse event was procedure related.The physician thinks it was due to transseptal puncture.The outcome of the adverse event was fully recovered (no residual effects).The patient required extended hospitalization because of the adverse event.The patient was moved to another hospital for intensive care service but no surgery has been needed.No evidence of a steam pop.Flow settings were usual.Correct catheter settings were selected on the generator.Pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error messages observed on the biosense webster, inc.Equipment during the procedure.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6) additional 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 31226451l 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).

• 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: 18984415
• MDR Text Key: 338658782
• Report Number: 2029046-2024-01026
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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: 31226451L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2024
• 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; LASSO NAV 2515,22P SPLITHANDLE; TRNSPTL FXD SHEATH,63CM,ML0; UNK PUMP; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening