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

Catalog Number D134702

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 09/21/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a non- ischemic ventricular tachycardia (isvt) ablation procedure using thermocool® smart touch® sf uni-directional navigation catheter.The patient experienced cardiac tamponade that required surgical intervention.For vt ablation, the user replaced 50% of the nacl irrigation solution with glucose.It was made aware that this violated the intended use and therefore, was an off-label use.A steam pop occurred in the area of the right ventricle (rv), free wall which led to a tamponade.This had to be surgically closed.The examination had to be stopped, the case was not finished.The physician's opinion on the cause of this adverse event was the procedure.Outcome of the adverse event was that vt was inducible but emergency surgery had to be performed.The patient required extended hospitalization due to the emergency surgery.The steam pop occurred during the last ablation.The generator used at the time of steam pop was smartablate.Generator parameters was power control mode, power cut off: 35w.The ablation cycle was 10 seconds when the pop was observed at the same tip position.No errors on bwi system.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 19-dec-2023 providing the physician information.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 UNI-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: 17962624
• MDR Text Key: 326006462
• Report Number: 2029046-2023-02373
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• 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: UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male