X
OK Your changes have been successfully saved
SFDA Home Page
Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 119 10 18 000
Date submitted: 10/23/2018
Manufacturer:Biosense Webster Inc.
Device Type:THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter & THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter
Description:Catheters, Cardiac, Ablation
Medical Device Identifier:Catalog No: D1347XX, D1348XX, D1347XXIL, D1348XXIL
Reason of Field Safety Corrective Action:Through the post-market surveillance process, Biosense Webster, Inc. has observed a higher than expected reported rate of char formation for the THERMOCOOL SMARTTOUCH SF Uni-Directional Navigation Catheter and the THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter (collectively, the “THERMOCOOL SMARTTOUCH SF Catheters”).
Remedy Action:Biosense Webster is providing the following recommendations to reduce the potential for excessive temperature and char occurrence when using THERMOCOOL SMARTTOUCH® SF Catheters. Workflow recommendations are summarized below to optimize the performance of the device:
1. Reduce ablation duration.
2. Reduce contact force to 5-25 grams.
3. Use only prescribed irrigation rate for a specified power output.
• For power levels up to 30 W, a high flow rate of 8 mL/min should be used
• For power levels 31W and above, a high flow rate of 15 mL/min should be used
4. Increase the irrigation to high flow rate starting up to 5 seconds before the onset of RF energy delivery.
The application of RF energy must not be initiated until the increase in irrigation flow rate is confirmed by a minimum of 20C decrease in tip electrode temperature.
5. When using the CARTO VISITAG™ Module, the following settings are recommended:
• Stability Distance: Maximum Change 2-3 mm
• Stability Time: Minimum 3 seconds
• VISITAG Module settings: Tag size of 3 mm
• Force Over Time: 25% over 3grams
6. The combination of reduced stability range, extended stability time, or elevated threshold for force over time, may result in excessive temperature at ablation site.
7. Do not rely on the catheter tip temperature response to guide ablation. If temperature increases rapidly, stop RF application immediately. Monitoring the temperature behavior from the electrode during the application of RF energy ensures that the irrigation flow rate is being maintained.
8. Connect the irrigation tubing to a room temperature, heparinized (1 IU heparin/mL) normal saline bag using standard safe hospital practices. The use of dilute irrigation fluid (i.e., half-normal saline) has not been evaluated.
Athorized Representative/Importer/Distributor:Johnson & Johnson Medical Saudi Arabia Limited
Report Source:NCMDR
Source Ref. Number:45E5A0A327294
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Biosense Webster Inc..pdf