Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its Imager II Angiographic Catheter - 5 French Curved Tip Shapes.
(For affected product details, please refer to the manufacturer's FSN)
The manufacturer is initiating a removal of the Imager II Angiographic Catheters - 5F curved tip shapes which includes all lots/batches of this 5F configuration. This removal is an expansion to a retrieval of 12 specific batches of this catheter which was initiated in February 2020. The manufacturer has identified an increase in the rate of tip detachment complaints on the 5F curve tip shapes configuration. Investigation has now concluded the need to expand the scope to all lots/batches of the 5F curved tip shapes. There have been three patient injuries reported since the initial removal of products earlier this year.
The manufacturer's investigation has concluded the failure is generated by exposure to high humidity and temperature storage conditions and other potential variables that include aging of the units, the amount of stabilizer remaining in the resin used to manufacture the catheter and the manufacturing process to curve the product. No other Imager II catheters are impacted by this removal.
The most common injury related to the tip detaching inside the patient would be the need for intervention to retrieve the fragment or the fragment remaining in the patient's vessel, potentially requiring additional intervention and/or prolonged hospitalization. There is a possibility that a potentially life-threatening embolism of the device fragment could result.
The manufacturer recommends users to cease immediately further distribution or use of any remaining products affected by this removal. Product removal is on-going.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 August 2020