As per an Early Alert from the US Food and Drug Administration (FDA), Boston Scientific has issued a letter to affected customers recommending that certain percutaneous catheters should be removed from where they are used or sold. Affected devices include the company’s Enroute transcarotid neuroprotection system (NPS) and Enroute transcarotid NPS Plus.
Boston Scientific has stated that it is initiating the removal of specific lots of these systems due to reports of arterial sheath tip separation or partial tip separation during use. The US FDA alert details that tip separation may require endovascular or surgical retrieval of the retained tip, with embolism, stroke, transient ischaemic attack, restenosis, or thrombosis, being among potential associated complications.
As of 9 July, Boston Scientific has reported one serious injury and no deaths associated with this issue.
On 9 July, the company 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 devices
- If any systems have been forwarded to another facility, contact that facility and provide them with the firm’s notice
The US FDA states that updates will be available via the following webpage: https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-percutaneous-catheter-issue-boston-scientific.
“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,” the regulator also notes in its Early Alert, dated 24 July.
