Indications, Safety, and Warnings DxTerity and DxTerity TRA Diagnostic Catheters

DxTerity™ diagnostic catheters are available in various configurations and French sizes.


Indications for use

The diagnostic catheter is indicated for cardiac and vascular procedures. It is designed to deliver radiopaque media, guidewires, and therapeutic agents to selected sites in the vascular system. The different configurations of the diagnostic catheter are designed to be used in arteries from access sites such as the radial, brachial, and femoral arteries.


Contraindications

None specific to this device.


Warnings and precautions

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

General

  • 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 contamination of the device, which could result in patient injury, illness, or death. Cleaning, disinfection, and resterilization may compromise the essential material and design characteristics of the device and lead to device failure.
  • Do not use the diagnostic catheter if it has been damaged or any other anomaly is observed.
  • Do not use after the Use-by Date.
  • Use aseptic technique during the entire procedure.
  • Warning: Administer appropriate anticoagulation therapy to reduce potential thrombosis. If the patient is not appropriately anticoagulated, thrombus formation may occur. Testing without anticoagulation shows variable amounts of thrombus formation on the device surface.
  • After use, this product may be a biohazard. Handle and dispose of all such devices in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.
  • Only physicians trained in intravascular angiographic procedures should use or supervise the use of the diagnostic catheter.
  • Carefully inspect the diagnostic catheter before use to verify that the size, shape, and condition of the catheter are suitable for the intended procedures.
  • Store diagnostic catheters in a cool, dry, and dark area.
  • Do not expose diagnostic catheters to UV light.
  • The diagnostic catheter is supplied sterile and nonpyrogenic. Do not use the catheter if the catheter package has been opened or damaged before use.
  • Do not heat or bend the diagnostic catheter before use.
  • Select a diagnostic catheter with optimal tip shape and optimal size, taking into account the access site, the target site, and the patient's anatomy. 

Interactions

  • When using a drug or device with the diagnostic catheter, be aware of the properties and characteristics of the drug or device and exercise due caution to avoid damaging the diagnostic catheter.
  • Avoid using alcohol, antiseptic solutions, and other solvents with the diagnostic catheter.

Table 1. Diagnostic Catheter Flow Rate

French Size Flow Rate Maximum Permissible Pressure (psi/kPa)
Maximum Flow Rate (ml/sec) Pressure (psi/kPa)
5 F (1.67 mm) 19 600 psi/4137 kPa 1200 psi/8274 kPa
27 1200 psi/8274 kPa
6 F (2.00 mm) 28 600 psi/4137 kPa 1200 psi/8274 kPa
40 1200 psi/8274 kPa

All measurements were taken using 100-cm diagnostic catheter samples using a solution of 50% Isovue-300/50% saline by volume at 37°C.

Adverse events

Adverse events that may occur or require intervention include, but are not limited to, the following:

  • Thrombus formation
  • Embolization
  • Infection
  • Arterial, venous, or heart wall damage or perforation
  • Plaque dislodgement
  • Hematoma at puncture site
  • Cardiac arrhythmia
  • Myocardial infarction
  • Vascular occlusion
  • Death
  • Access site pain
  • Allergic and neurological reactions
  • Vasospasm
  • Stroke and Transient Ischemic Attack
  • False aneurysm
  • Arteriovenous fistula

Instructions for use

  1. Carefully remove the diagnostic catheter from the package.
  2. Flush the diagnostic catheter with heparinized saline solution.
  3. The diagnostic catheter may be introduced into the selected vessel by Cut down technique, Seldinger technique, or introducer methods. When using an introducer, ensure that it is a French size greater than or equal to the selected diagnostic catheter.
  4. Introduce the diagnostic catheter into the vascular system over a guidewire and carefully advance it under fluoroscopic control.
  5. To remove the diagnostic catheter, reinsert the guidewire to straighten the tip of the diagnostic catheter. Slowly withdraw the diagnostic catheter and guidewire under fluoroscopic control. Medtronic recommends using aspiration during withdrawal.