Early Alert: Percutaneous Catheter Issue from Boston Scientific

CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.Affected Product ENROUTE NPS ENROUTE NPS PlusThe FDA is aware that Boston Scientific has issued a letter to affected customers recommending certain Percutaneous Catheter be removed from where they are used or sold.Affected devices:ENROUTE Transcarotid Neuroprotection System (NPS) ENROUTE Transcarotid Neuroprotection System Plus (NPS Plus)Full list of affected lotsWhat to DoDo not use affected product. Identify affected product, cease use and distribution, and return to Boston Scientific.

On July 9, Boston Scientific sent all affected customers a letter recommending the following actions:Immediately stop further use or distribution and segregate affected product Return product to Boston Scientific Notify relevant personnel in your facility who use these devicesIf any systems have been forwarded to another facility, contact that facility and provide them with the firm’s noticeCheck this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.Reason for AlertBoston Scientific stated they are initiating the removal of specific lots of ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus due to reports of arterial sheath tip separation or partial tip separation during use.Tip separation may require endovascular or surgical retrieval of the retained tip. Complications associated with a retained tip include embolism, stroke, transient ischemic attack, restenosis, or thrombosis.

As of July 9, Boston Scientific has reported one serious injury and no deaths associated with this issue.Device UseThe ENROUTE Transcarotid System is designed to transport emboli away from the carotid artery circulation by reversing blood flow at the treatment site prior to crossing a lesion in the carotid artery and during lesion manipulation. Contact InformationCustomers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Boston Scientific at BSCFieldActionCenter@bsci.com or call (763) 415-7708.Unique Device Identifier (UDI) The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use.

The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.How do I recognize a UDI on a label?AccessGUDID database - Identify Your Medical DeviceBenefits of a UDI SystemHow do I report a problem? Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.