Recall of ThermoCool SmartTouch Catheter Family (used to facilitate electrophysiological mapping of the heart and to undertake RF ablations)

Recall

RC-2014-RN-01156-1

Class I

2014-10-28

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01156-1

Biosense webster, a division of johnson & johnson medical pty ltd have received complaints related to a bending/cracking at different locations of the shaft of the thermocool smarttouch catheter. none of the reported complaints were associated with any adverse events. through investigation, manual pre-shaping of the distal shaft of the catheter and use of 8 fr sheaths were identified as the two primary causes of these events. based on biosense webster's investigation, including a medical evaluation of the health risk profile from the post-market reports, biosense webster believes the overall benefit risk profile of these catheters remains in an acceptable range when used as directed in the indicated populations.

Johnson & Johnson Medical Pty. Ltd (JJM) is notifying their customers of additional information included in the IFU: - Do not manually pre-shape the distal shaft of the catheter by applying external force intended to bend or affect the intended shape or curve of the catheter. - It is contraindicated to use any long sheath or short introducer < 8.5Fr in order to avoid damage to the catheter shaft. (Note: This contraindication includes Biosense Webster’s 8Fr Preface Sheath that was recommended in the initial IFU.) - Do not use excessive force to advance or withdraw the catheter if resistance is encountered during catheter manipulation through the sheath JJM is also reinforcing the procedural steps and precautions set out in the IFU - Do not use excessive force to advance or withdraw the catheter when resistance is encountered. -To verify compatibility between the sheath and catheter, advance the catheter through the sheath prior to insertion. This action has been closed-out on 15/07/2016.