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, Medtronic Inc., has issued a medical device safety alert concerning its Ascenda Intrathecal Catheter [HKMD No.: 090082].
According to the manufacturer, there is a design update to the Model 8780, 8781, and 8784 Ascenda Intrathecal catheters (Ascenda catheter). The Ascenda catheter design update focuses on improvement of the catheter connector seal quality to reduce the probability of tissue growth into the connector that attaches to the SynchroMed pump.
The manufacturer is not recommending prophylactic replacement of the current Ascenda catheter design due to the low observed occurrence rate (0.06%) and the risks associated with replacement surgery. Instead, the manufacturer recommends re-emphasizing to patients and caregivers the signs and symptoms of withdrawal or return of underlying conditions.
The presence of tissue in the catheter connector may result in a prolonged surgical procedure due to extended troubleshooting (i.e., cleaning and re-attaching the connector or replacing the pump connector). If the presence of tissue in the catheter connector causes an obstruction, it may lead to return of symptoms, loss of therapy and/or life-threatening baclofen withdrawal.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 May 2024