Early Alert: Angiographic 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 The FDA is aware that Boston Scientific has issued a letter to affected customers recommending all Imager II Angiographic Catheters be removed from where they are used or sold.List of affected devicesWhat to DoThe Imager II Angiographic Catheters are used to create images of specific areas of interest in the peripheral vasculature.

Users should review and follow the instructions below for removal of these devices.On August 24, Boston Scientific sent all affected customers a letter recommending the following actions:Immediately stop further use or distribution and segregate affected product. Continue to follow the standard of care when monitoring patients treated with the product. Complete and return the enclosed Reply Verification Tracking Form (RVTF).

PLEASE NOTE: Health Care facilities often remove products from the outer carton and store them on shelves in the inner-pouch only. If this is a practice at your facility, it is very important to use the product table. Consider both the inner and outer packaging UPN codes when searching for affected product, since the UPN numbers on the inner and outer labeling are different.

The product information listed on your specific RVTF provides outer package product coding only and should be utilized when reporting product to return. Verify by UPN number whether any product within your inventory is affected. If so, indicate on your RVTF the quantity of units from each lot/batch that you will be returning.

Since the products in these lots/batches are sold in 5-packs, all reported quantities must represent the actual number of individual units being returned, not the number of cartons, boxes, or multi-packs. Return product to Boston Scientific. Forward this notice to relevant personnel and any facilities to which the product was transferred.Check 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 that the Imager II Angiographic Catheters are being removed due to a manufacturing issue affecting the catheter tip.Boston Scientific has determined that these catheters were manufactured with reduced levels of stabilizing agents in the tips. This may increase the risk of tip degradation and detachment.Although no increase in tip detachment complaints has been identified for the affected lots, the devices were manufactured outside the approved design specification and are being removed from the market. In addition, Boston Scientific has made the decision to discontinue selling this product.The most common adverse health consequence of tip detachment in the intravascular space with a likelihood of occurrence of every time used is a delay in procedure to exchange for a new device.

Although considered remote, the most serious potential adverse health consequence within the intravascular space is life threatening embolism resulting from a device fragment obstructing blood flow resulting in end organ failure.As of July 16, Boston Scientific has reported two serious injuries and no deaths associated with this issue.Device UseThe Imager II Angiographic Catheters are sterile, single use diagnostic intravascular catheters available in a variety of shapes and lengths. These catheters are used to create images of specific areas of interest in the peripheral vasculature.Contact Information Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Boston Scientific at BSCComplaints@bsci.com.Unique Device Identifier (UDI)The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use.

The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.How do I recognize a UDI on a label? AccessGUDID database - Identify Your Medical Device Benefits of a UDI System How 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.