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ProTrack™ Pigtail Wire

Indications, safety, and warnings

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions. 

ProTrack™ Pigtail Wire

INDICATIONS FOR USE

The ProTrack™ Pigtail Wires are intended for use in percutaneous transseptal procedures to introduce and position catheters and other interventional devices within the left heart. The device is not intended for use in the coronary arteries.

CONTRAINDICATIONS

There are no known contraindications for this device.

WARNINGS

  • DO NOT push, auger, withdraw or torque a pigtail wire against resistance until the cause of the resistance has been determined. Applying excessive force against unexpected resistance may cause damage to the pigtail wire, interventional device and/or vessel/organ.
  • When the pigtail wire is exposed to the vascular system, it should be manipulated while under high-resolution imaging guidance including fluoroscopy and/or echocardiography. Improper visualization of the guidewire may lead to misplacement, dissection, or perforation.
  • Inspect the pigtail wire prior to use for coil separation, kinking, appropriate distal tip flexibility or breakage. If the pigtail wire is damaged or defective, do not use it. Using a damaged or defective pigtail wire may cause vasculature damage and/or compromise pigtail wire performance. 
  • Laboratory staff and patients can undergo significant X-ray exposure during interventional procedures due to the continuous usage of fluoroscopic imaging. The exposure can result in acute radiation injury as well as increased risk for somatic and genetic effects. Therefore, adequate measures must be taken to minimize this exposure.

ADVERSE EVENTS

Potential complications associated with the use of the pigtail wire include, but are not limited to:

  • Vessel Perforation/Dissection/Trauma or Damage
  • Vessel Spasm
  • Hemorrhage
  • Access Site Complications/Hematoma
  • Thrombus/Thromboembolism
  • Allergic reaction
  • Vascular complication
  • Cardiac tamponade
  • Cardiac Perforation/Laceration
  • Conduction disorder
  • Embolism
  • Additional Surgical Procedure
  • Pericardial/pleural effusion
  • Sepsis/Infection/Inflammation
  • Foreign Body/Wire Fracture
  • Hemolysis
  • Hypovolemia
  • Myocardial Ischemia and/or Infarction
  • Stroke/Transient Ischemic Attack 
  • Vessel Occlusion
  • Wire Entrapment/Entanglement
  • Valve Complication

EP-1515204-AA