Magellan Robotic System (Catheter controller steering unit ) 의 리콜

Recall

RC-2015-RN-00341-1

Class I

2015-04-16

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00341-1

Hansen medical has recently become aware of an incident, which occurred during the catheter installation steps for peripheral vascular procedure. a magellan robotic catheter 6fr was manually inserted a short distance into the patient’s femoral artery, as required. however, during the subsequent catheter installation steps, system buttons were simultaneously pressed while removing, then reinstalling the guide wire support, which is a variation from the ifu instructions. during this sequence of steps, the user pressed a button to retract the catheter, installed the guide wire support, then released the button. the catheter did not stop retracting as expected when the button was released. instead, the system fully retracted the catheter, removing the introducer and patient patch along with the catheter, and vascular access was lost. this system behaviour can only occur during the catheter installation workflow and not during navigation or delivery of therapy.

If this situation should occur, Medtel is requesting the users to press the Emergency Stop button as described in the Magellan Robotic System Instructions for Use (IFU). Medtel is also scheduling field safety training and re-training the Magellan physician-operator to the information contained herein.