Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, St. Jude Medical (Abbott Medical), has issued a medical device safety alert concerning its Agilis NxT Steerable Introducer [Model: 408309; GTIN: 05414734206099; Affected Lot: 10071090] [HKMD No.: 100167].
According to the manufacturer, during preparation for the procedure, the dilator is inserted into the sheath. Because the dilator for the devices in the affected lot are too short, they will not extend out of the sheath. The physician uses the dilator to insert the introducer sheath into the vasculature. If the dilator does not extend past the sheath, this will be immediately identified and the device should be replaced. This issue is detectable prior to use and in the event this issue occurs, the physician should replace the device with an introducer from a different lot. The primary risk associated with this error is a minimal delay of procedure to replace the device, with low potential of resulting physical harm. Inserting the sheath into the femoral vein when the dilator does not extend out of the sheath or no dilator is used may result in vessel trauma. However, the issue is readily observable during device preparation and prior to insertion and should result in device replacement.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 02 May 2024