Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its VenaSeal Closure System [VenaSeal model: VS-402, SP-101, VS-403, VS-404].
The manufacturer has determined that in some cases, the trigger of the VenaSeal dispensing gun, which advances the plunger rod forward resulting in forward movement of the syringe plunger and adhesive, does not advance and dispense adhesive as intended. If the gun malfunctions, the issue can result in a prolonged procedure or an inability to complete treatment with the device. Additionally, if partial treatment is received, segments of open vein may remain, which could potentially lead to phlebitis in the treatment zone. The most common reported outcome has been an inability to finish the procedure with an affected gun.
The manufacturer is releasing an update to the adhesive delivery technique to address the issue. Affected users are advised to refer to the customer letter for details.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 24 March 2021