Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Opticross 35 8F Peripheral Imaging Catheter [UPN: H7493932800350; GTIN: 08714729984542; Batch: 25754545, 25852104, 25852106, 25856700].
The manufacturer is removing the Opticross 35 Peripheral Imaging Catheter following one complaint in which there was flaking of the markings on the device. This potential issue relates only to units from the affected batches. No patient harm has been reported.
The most common potential adverse health consequence would be prolonged procedure to exchange the catheter for another as this potential issue is observable and has occurred outside of the patient's body. The most severe health consequence that is reasonably expected to occur if a catheter with this potential issue used is embolization which would result if the flaking marks advance while flushing the catheter.
According to the manufacturer, affected users are instructed to immediately segregate the affected products to ensure that it will not be used, and return the affected products to the manufacturer. Product removal is on-going.
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 26 August 2020