Medical device manufacturer, Boston Scientific, has issued a field safety notice regarding the RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation Device that is used in conjunction with the Rotablator Rotational Atherectomy System. The affected material numbers, batch numbers and batch expiration date range are shown below:

• Material number (Batch number):
  • H802223301, H802223300 (18201519, 18212726, 18256610, 18261218, 18271412, 18282032, 19362094, 18378161, 18379210, 18384443)
  • H802233301 and H802233300 (18141187, 18194620, 18220238, 18261834, 18285502, 18303265, 18390089)
• Batch expiration date range: 25 June 2017 through 9 September 2017

The manufacturer has received three complaints for wire fracture. One fracture occurred during device prep, and the other two fractures occurred during the procedure resulting in burr migration into the pericardium. One of these involved placement of a covered stent to address vessel perforation. That patient subsequently expired. The other required surgery for removal of the fragment.

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 products, please contact your supplier for necessary actions.

Posted on 16 October 2015</p