ThermoCool SF NAV Catheter Family 의 리콜

Recall

RC-2014-RN-00588-1

Class I

2014-05-26

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00588-1

Due to a higher frequency of reported adverse events related to cardiac perforations and atrio-esophageal fistula johnson & johnson medical is updating the ifu to include the following information:- verify that the catheter selection knob on the compatible rf generator is on the “tcool sf” or thermocool sf similar option and ensure that the maximum temperature is set at 40°c- do not rely on electrode temperature rise to determine if tissue heating is occurring during rf energy delivery as bench and animal studies showed no significant electrode temperature rise during rf ablation.J & j is also providing information to reinforce procedural steps and precautions set out in the ifu.

J & J is notifying their customers of additional information included in the IFU: - Verify that the CATHETER SELECTION KNOB on the compatible RF generator is on the “Tcool SF” or Thermocool SF similar option and ensure that the maximum temperature is set at 40°C - Do not rely on electrode temperature rise to determine if tissue heating is occurring during RF energy delivery as bench and animal studies showed no significant electrode temperature rise during RF ablation. J & J is also providing information to reinforce procedural steps and precautions set out in the IFU.