Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Capio Suture Capturing Devices and Pelvic Floor Kits. The affected products are as follows: -
The manufacturer observed a gradual increasing trend in reports regarding the Capio suture breakage and/or detachment of the Capio suture darts from both the Capio suture and the pelvic floor kit mesh assembly. The mesh assembly refers to the portion of the pelvic floor delivery system which is removed from the patient following implantation of the mesh.
As a result, the manufacturer is voluntarily initiating a Product Advisory to the technique for use of the Capio Suture Capturing Devices and the Uphold LITE with Capio SLIM Vaginal Support System, and Pinnacle LITE Posterior with Capio SLIM Pelvic Floor Repair Kits.
According to the manufacturer, Capio suture breakage and/or detachment of the Capio suture darts occurs when higher amounts of counter-traction (tension) are placed on the Capio suture or pelvic floor kit mesh assembly during deployment. The most common reported injury has been a prolonged procedure beyond anticipated/expected duration. In some cases, the manufacturer has received reports of suture breaks resulting in un-retrievable device fragments. Although the risk-benefit assessment of further intervention varies from case to case, extensive dissection to attempt removal of retained fragments is typically not recommended.
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 14 February 2018