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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 011 12 13 000
CoreValve AccuTrak Delivery Catheter System (DCS)
Intended to deliver CoreValve Transcatheter Aortic Valve, which is designed to treat severe aortic valve stenosis without open-heart surgery or surgical removal of the native valve.
Medical Device Identifier:
Models DCS-C4-18Fr and DCS-C4-18Fr-23
Reason of Field Safety Corrective Action:
Medtronic has determined that the following situations can lead to nose cone separations:
Using the CoreValve AccuTrak DCS to retrieve (remove) a partially deployed valve.
Removing the CoreValve AccuTrak DCS from the patient, after valve deployment, without fully closing the CoreValve AccuTrak DCS capsule.
Continuing to pull on the CoreValve AccuTrak DCS if increased resistance is felt at the vessel introducer, the introducer’s hemostatic valve, or other structure during CoreValve AccuTrak DCS retrieval.
To reduce the occurrence of nose cone separations, Medtronic is modifying the instructions for use (IFU) and training materials for CoreValve AccuTrak DCS models DCS‐C4‐18Fr and DCS‐C4‐18Fr‐23; however no product returns are necessary.
( Please see attached for more information )
Gulf Medical Co., (012)6512828
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.