Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning the following drainage catheters:
- Expel Drainage Catheter with Twist-Loc Hub and Biliary Drainage Catheter Kit
- Expel Drainage Catheter with Twist-Loc Hub APDL Drainage Catheter and APDL Drainage Catheter Kit
- Expel Drainage Catheter APD Drainage Catheter
- Expel Large Capacity Drainage Catheter APD Large Capacity Drainage Catheter
The manufacturer has received one complaint (Expel APD) and 11 complaints (Expel Drainage Catheter with Twist-Loc Hub and Biliary Drainage Catheter Kit) of device fragmentation after the catheter was implanted in the biliary system. According to the manufacturer, the most serious foreseeable patient risk for this issue is additional intervention for fragment retrieval using minimally invasive methods.
The manufacturer advises affected users of the following:-
- Do not use the Expel APD and APDL Drainage Catheters for bile drainage. Other than for bile drainage, affected users may continue to use the Expel APD and APDL Drainage Catheters according to the Directions for Use.
- The Expel Drainage Catheter with Twist-Loc Hub Nephrostomy Drainage Catheter and Nephrostomy Drainage Catheter Kit are not indicated for use in the biliary system and these devices must be used in a manner that is consistent with the device's Directions for Use.
- The Expel APD, APDL, Nephrostomy Drainage Catheters are not being retrieved and must not be used for bile drainage.
- Further distribution or use of any remaining unused products should cease immediately.
- For biliary catheters that are already implanted, physicians should monitor their patients following their judgment and standard of care.
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 04 March 2015