Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its ACUITY Pro Coronary Sinus 9Fr Outer Guide Catheters. [Product model: 8104 – 8119, lot number: multiple]
The ACUITY Pro 9Fr Guide Catheter is designed to provide a pathway into the coronary venous system for implantation of a left ventricular pacing lead. The Catheter has a proximal handle with an integrated hemostasis valve and a shaft with a flexible distal segment. Once the left ventricular lead is placed, the handle and distal segment are cut and removed.
The manufacturer has received reports of handle separations during the cut and removal process; there have been no reported patient harms.
After full investigation, the manufacturer concludes that if the hub and shaft are aligned off-centre in the bonding equipment during manufacturing; the result may be a reduced bond, which may separate during cutting. The affected product lots were manufactured during the period when the equipment was likely to be misaligned.
Product recall is ongoing.
According to the local supplier, the affected lots are not distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 30 November 2015