Events

Safety Alert for PENTARAY Catheters

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Biosense Webster.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-04-21
  • Event Date Posted
    2016-04-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160421.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: biosense webster pentaray catheters medical device manufacturer, biosense webster, has issued a medical device safety alert concerning its pentaray catheters. this involves all lots of pentaray catheters with catalogue numbers d128201, d128202, d128203, d128204, d128205, d128206, d128207, 0128208, d128209, d128210, d128211, and d128212. pentaray catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.E., recording or stimulation only. this catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. the manufacturer is updating the contraindication language in the instructions for use (ifu) and product labeling for this catheter relative to patients with prosthetic valves. the current language in the ifu provides a precaution against use of the pentaray catheter in patients with prosthetic valves under the contraindication section stating: “[the] use of this catheter may not be appropriate for use in patients with prosthetic valves.” the manufacturer is updating the contraindication statement as follows: “do not use pentaray catheters in patients with prosthetic valves”. according to the manufacturer’s medical assessment, there is a high risk of catheter spline entanglement when using pentaray catheters in patients with prosthetic valves. if excessive force is applied on the entangled catheter spline, there is a potential for parts to detach and embolize inside the patient’s body, which may lead to serious complications like stroke, transient ischemic attack, myocardial infarction or pulmonary embolism. the likelihood of these serious complications remains low. the manufacturer advises users that they may continue to use pentaray catheters in accordance with the updated contraindication. 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 21 april 2016.

Device

PENTARAY Catheters
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Biosense Webster PENTARAY Catheters
  • Manufacturer
    Biosense Webster

Manufacturer

Biosense Webster