Indications, Safety, and Warnings TRAcelet Compression Device

Important Information

Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warning and precautions.


Indications for Use

The compression device is used to assist hemostasis of the radial artery after a transradial procedure. The closure band can be adjusted for the maintenance of patency using precisely controlled pressure applied to the radial artery.


Contraindications

  • Patients with an abnormal Allen's test, abnormal Barbeau test, abnormal radial pulse, or insufficient dual arterial supply
  • Patients with infection or other serious skin disease at the access site

Warnings

Caution: Read all instructions carefully. Failure to properly follow the instructions, warnings, and precautions may lead to serious consequences or injury to the patient.

  • For single-patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a new risk of device contamination, which could result in patient injury, illness, or death. Cleaning, disinfection, and resterilization may compromise essential material and design characteristics of the device and lead to device failure.
  • The syringe provided should be used only to inject air into the compression balloon of the closure band. If an introducer sheath is in place, do not inject air into the introducer sheath.
  • When in use, do not put excessive load on the compression balloon, which could damage or alter the performance of the device.
  • Do not inject more than a total of 18 mL of air. The closure band may be damaged if this volume is exceeded.
  • Do not soak or wipe with agents containing organic solvents. Such agents may cause damage to the closure band.
  • The patient should not be left unattended while the closure band is in use.

Precautions

  • This device is intended for use by trained personnel.
  • During the procedure, only use the syringe provided to adjust air pressure in the compression balloon.
  • When connecting a syringe to the closure band, keep the syringe plunger in place to prevent loss of air compression in the compression balloon. Loss of air compression may cause bleeding.
  • Ensure that no foreign particles enter the air valve when injecting air to avoid air leaking.
  • If there is itching or redness of the skin during compression, stop using the closure band and treat appropriately. Dial markings do not indicate a specific pressure or compression balloon volume and should be used for relative reference only.
  • Do not use this product if the unit package or the product has been damaged or soiled.
  • Use this product immediately after opening the package.
  • Avoid exposure to water, direct sunlight, extreme temperatures, or high humidity during storage.
  • After use, this product may be a potential biohazard. Handle and dispose of all such devices in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.

Adverse Events

Depending on the patient’s condition and the degree of compression balloon pressure, potential adverse events include, but are not limited to, the following:

  • Artery occlusion
  • Arterial or venous embolization
  • Hemorrhage
  • Hypodermic hematoma
  • Numbness
  • Infection
  • Allergic reaction
  • Pain

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a licensed healthcare practitioner.

See package inserts for the full product information.

Please contact your local Medtronic sales representative for more information.