Dear Healthcare Professional Letters
Update to the Instructions for Use of CoreValve™ AccuTrak™ Delivery Catheter System
Audiences
Healthcare professional
Product type
Medical devices
11 December 2013
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Medtronic International, Ltd. (Medtronic) would like to inform healthcare professionals of an update to the Instructions for Use (IFU) of the CoreValve™ AccuTrak™ Delivery Catheter System (DCS). Medtronic is initiating this update as reports of nose cone separation during the use of the CoreValve™ AccuTrak™ DCS have been received. Investigations of the reported events has identified that a majority of these events occurred in situations where the CoreValve™ AccuTrak™ DCS was used in ways cautioned against in the current IFU. While none of the events resulted in permanent patient harm, additional patient risks, such as bleeding at the access site and embolism, could result. Medtronic has advised healthcare professionals to review the updates to the IFU and training materials. Healthcare professionals are advised to refer to the Dear Healthcare Professional Letter for more details.
Only abstracts of the Dear Healthcare Professional Letters (DHCPL) are provided on this website. Details of these letters can be found in the MOH Alert System, which is accessible via the Health Professionals Portal (HPP), a one-stop portal for all healthcare professionals in Singapore. Dentists, medical doctors and pharmacists may access HPP at https://hpp.moh.gov.sg and follow the procedures below to access the MOH Alert system.
Step 1: Select your profession under ‘For Healthcare Professionals’.
Step 2: Click on ‘Useful links’.
Step 3: Click on ‘MOH Alert’ and log in via Singpass.
Step 4: Click on ‘Drug Alerts’ or ‘Med Device Alerts’ to view the DHCPLs.