sábado, 8 de agosto de 2015

FDA MedWatch - Beacon Tip Angiographic Catheters by Cook Medical: Class 1 Recall - Catheter Tip May Slip or Separate

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Beacon Tip Angiographic Catheters by Cook Medical: Class 1 Recall - Catheter Tip May Slip or Separate

  • Beacon Tip Torcon NB Advantage Catheters
  • Beacon Tip Royal Flush Plus High-Flow Catheters
  • Slip-Cath Beacon Tip Catheters
AUDIENCE: Risk Manager, Nursing, Radiology, Surgery, Critical Care Medicine, Anesthesiology
ISSUE: Cook Medical has received complaints that the catheter tip may split or separate from the catheter. If this occurs, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death. Tip splitting or separation may also cause the device to stop working.
Cook Medical has received 26 reports of the device malfunctioning, with 14 resulting in reports of adverse events. See the FDA Recall Notice for a link to a complete list of lot numbers affected.
BACKGROUND: Beacon Tip Angiographic Catheters are used to inject contrast dye into blood vessels in the heart to prepare it for a type of X-ray used to diagnose heart conditions (cardiac angiogram).The catheter is inserted into the body through a small puncture made in the skin and placed into the blood vessel along a guide wire before injecting the contrast dye.
RECOMMENDATION: On July 2, 2015, Cook Medical sent their customers an Urgent: Medical Device Recall letter. The letter instructed customers to immediately quarantine unused products from their inventory and Collect and return all unused products to Cook Medical as soon as possible. Customers can contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235, Monday through Friday between 7:30 a.m. and 5:00 p.m., Eastern Time.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
For the MedWatch Safety Alert, including link to the FDA Recall Notice: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm457663.htm

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