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Cook Medical Beacon Tip Angiographic Catheters

These heart catheters are manufactured by Cook Medical and assist with inserting dye for cardiac angiograms, which are imaging procedures. The dye illuminates the heart chambers, valves and major vessels.

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Cook Medical Beacon Tip Angiographic Catheters are used during angiographic procedures, which can help diagnose and treat heart conditions. 1 Cardiac catheters, such as the Beacon Tip Cook Medical ones, allow cardiologists to inject contrast dye into blood vessels in the heart so that a specialized X-ray “movie” called a cardiac angiogram can be taken. 2

This type of procedure involving an angiographic catheter is called a cardiac catheterization. The examination enables doctors to monitor blood flow and movement, as well as pressures, within the heart. Depending on what the doctor finds, some conditions can also be treated during the procedure. 3

Cook Catheter and Heart Catheterization Procedure

Typically, during a cardiac catheterization procedure, you are given medication to help you relax, but you remain awake throughout the examination. 4 Initially, a sheath — a larger, thin, flexible tube — is inserted into a blood vessel in your leg, arm, neck or groin and then longer plastic tubes called catheters are inserted. A special X-ray machine shows the doctor how to weave the catheter through the blood vessel to the coronary arteries. 5

The cardiologist may inject contrast dye through the catheter, which begins to show up on the X-ray movie as it makes its way through the heart. The chambers, valves and major vessels are illuminated. 6 This procedure is called a coronary angiogram.

Treating Coronary Heart Disease and Other Conditions

The dye that may be inserted through a cardiac catheter makes your heart’s coronary arteries visible. If a waxy substance known as plaque has begun to accumulate in your arteries, the dye can reveal this condition, called coronary heart disease. Plaque can reduce blood flow to your heart. 7

At this time, the doctor may be able to take steps to open the coronary artery, improving blood flow. These interventional procedures may include angioplasty (the insertion of a tiny balloon that is inflated to push plaque outward in an attempt to reopen the artery) or stent placement (a small tube that can be placed in attempt to keep the artery open). 8

Other possible treatments could involve closing a hole in the wall between the heart’s upper chambers (the atria) or other congenital defects, closing off parts of the heart to prevent blood clots, treating heart arrhythmias (ablation), or performing other procedures. 9

Additional imaging procedures may also be done to help the doctor visualize the walls of the blood vessels in greater detail and produce more accurate pictures of the location and extent of blockage due to plaque. 10

Evaluating Heart Problems

Your doctor may choose to perform other procedures during your cardiac catheterization. These may include:

  • Taking samples of blood or heart muscle
  • Measuring oxygen levels throughout the heart
  • Checking the heart’s pumping function (ventriculogram)
  • Diagnosing congenital heart defects (those that are present from birth) 11

Recall of Cook Medical Beacon Tip Angiographic Catheter

On July 2, 2015, Cook Medical took voluntary measures to recall 2,239 lot-specific Beacon Tip Angiographic Catheters. The FDA has classified this recall as a Class 1 recall, which means “there is a reasonable probability that the use of or exposure…will cause serious adverse health consequences or death.” Worldwide, there are 95,167 devices affected. 12

According to a Cook Medical press release, “Beacon Tip Angiographic Catheters have been found to exhibit tip splitting or separation, which has resulted in adverse events.” 13

Tip splitting can lead to device malfunction. The company also points out that “Tip separation may require medical intervention to retrieve a separated segment or may occlude blood flow to end organs.” 14

The Beacon Tip Angiographic Catheters affected by this recall were distributed between June 6, 2013 and June 25, 2015. The affected catheters include the Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, and the Slip-Cath Beacon Tip Catheters. 15

  1. https://medlineplus.gov/ency/article/003419.htm; http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm457629.htm; http://www.nhlbi.nih.gov/health/health-topics/topics/cath 

  2. http://www.heart.org/idc/groups/heart-public/@wcm/@hcm/documents/downloadable/ucm_317626.pdf; http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm457629.htm 

  3. http://www.heart.org/idc/groups/heart-public/@wcm/@hcm/documents/downloadable/ucm_317626.pdf  

  4. https://medlineplus.gov/ency/article/003419.htm 

  5. http://www.mayoclinic.org/tests-procedures/cardiac-catheterization/basics/definition/prc-20023050; https://medlineplus.gov/ency/article/003419.htm 

  6. http://www.nhlbi.nih.gov/health/health-topics/topics/cath 

  7. http://www.nhlbi.nih.gov/health/health-topics/topics/cath 

  8. https://medlineplus.gov/ency/article/007473.htm 

  9. http://www.mayoclinic.org/tests-procedures/cardiac-catheterization/basics/why-its-done/prc-20023050 

  10. http://my.clevelandclinic.org/services/heart/diagnostics-testing/invasive-testing/cardiac-catheterization 

  11. http://www.nhlbi.nih.gov/health/health-topics/topics/cath; http://www.mayoclinic.org/tests-procedures/cardiac-catheterization/basics/why-its-done/prc-20023050 

  12. http://www.fda.gov/Safety/Recalls/ucm457068.htm; http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm457629.htm; http://www.fda.gov/Safety/Recalls/ucm165546.htm 

  13. http://www.fda.gov/Safety/Recalls/ucm457068.htm 

  14. http://www.fda.gov/Safety/Recalls/ucm457068.htm 

  15. http://www.fda.gov/Safety/Recalls/ucm457068.htm; http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm457629.htm