Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Percuflex Urinary Diversion Stent 6Fr [Material number (UPN) M0061603250; batch numbers: 19347611, 19347612, 19347613] and 7Fr [Material number (UPN) M0061603300; batch numbers: 19664322, 19698112, 19740986].
The manufacturer is implementing the Medical Device Removal on certain lots of Percuflex Urinary Diversion Stent Kits in Japan only. During the manufacturing process, a swap in the 6Fr connectors and 7Fr connectors led to the wrong size connectors being included with the stents (i.e. 6Fr connectors were packaged with 7Fr stents, and 7Fr connectors were packaged with 6Fr stents). This may result in inability to connect a 7Fr stent to the 6Fr connector, or an insecure connection between a 6Fr stent and a 7Fr connector.
According to the manufacturer, the most likely adverse effect of these occurrences is a minimal delay in procedure. The customers are advised to discontinue use of and segregate the affected product immediately. Product recall is on-going.
According to the local supplier, the affected products are NOT distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 December 2016