The Therapeutic Goods Administration (TGA) of Australia has posted a medical device safety alert concerning ARROW Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits manufactured by Arrow International, Inc.
The Arrow Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits contain a percutaneous sheath introducer. The Percutaneous Sheath Introducer is used by some clinicians in the Intra-Aortic Balloon Catheter insertion procedure. The issue pertains to the sheath introducer in the insertion kit only. The other components of the kits are unaffected.
The manufacturer has advised there is the possibility that the percutaneous sheath introducer body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. If bleeding is not addressed with prompt intervention, it may result in loss of significant blood volume or exsanguination. In addition, delay of treatment, interruption of treatment, or loss of Intra-Aortic Balloon therapy can occur.
The manufacturer is advising customers to immediately quarantine all affected kits. The manufacturer will deliver replacement kits to the affected customers before the recovery of the affected kit.
The manufacturer advises users that in the case of an emergency situation before the replacement kit can be delivered, the Arrow Intra-Aortic Balloon Catheter can be inserted through the following alternative 8 Fr. sheaths: -St Jude Medical Diag Maximum -Terumo Pinnacle -Cordis Avanti
For details, please refer to the TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2016-RN-00204-1
If you are in possession of the affected products, please contact your supplier for necessary actions
Posted on 26 February 2016