PRODUCT CATALOG

Electrophysiology | Therapy | Irrigated Ablation Catheters

Therapy™ Cool Path™ Ablation Catheters 4 mm Tip Thermocouple

Quadripolar 7 F

Product Highlights

  • All braided shaft
  • Double mesh stainless steel braiding to the distal tip
  • Six equidistant ports on the distal tip
  • Uni-directional steering
  • Push/pull handle


Ordering Information

Contents: 7 F irrigated ablation Catheters (1 unit per box)

Reorder Number Description Electrode Spacing (mm) Tip Electrode (mm) Band Electrode (mm) Curve Type Usable Length (cm)
IBI-84308 1304-CP-7-25-M-AB 2-5-2 4 2 Medium 110
IBI-84309 1304-CP-7-25-L-AB 2-5-2 4 2 Large 110
IBI-84310 1304-CP-7-25-XL-AB 2-5-2 4 2 X-Large 110
IBI-84311 1304-CP-7-25-FL-AB 2-5-2 4 2 Flutter 110
IBI-84312 1304-CP-7-25-L1-AB 2-5-2 4 2 Large1 110

Required Catheter Connecting Cable

Reorder Number Compatible Generator
IBI-85641 SJM
Therapy™ Cool Path™ Ablation Catheters 4 mm Tip Thermocouple uadripolar 7 F


Rx Only

Brief Summary: Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

INDICATIONS

The Therapy Cool Path Duo and Safire BLU Duo Irrigated Ablation Catheters are intended for use with a compatible irrigation pump and the 1500T9-CP RF Generator at a maximum of 50 watts. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical Atrial Flutter. The Therapy Cool Path and Safire BLU Irrigated Ablation Catheters are intended for use with a compatible external infusion pump and the 1500T9-CP RF Generator at a maximum of 50 watts. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical Atrial Flutter.

CONTRAINDICATIONS

In patients with active systemic infection. Via the retrograde transaortic approach in patients with aortic valve replacement. Via the transseptal approach in patients with left atrial thrombus or myxoma, or interatrial baffle or patch. In patients with intracardiac mural thrombus, ventriculotomy or atriotomy within the preceding four weeks.

WARNINGS

Catheter ablation procedures present the potential for significant x-ray exposure. The long-term risk of protracted fluoroscopy has not been established. Careful consideration must be given for the use of the device in prepubescent children and pregnant women. The long term risks of RF ablation lesions have not been established. Patients undergoing AV nodal modification or ablation of septal accessory pathways are at risk for inadvertent AV block. The temperature data transmitted by the sensor in this catheter is representative of the irrigated electrode only and does not provide tissue temperature data. Always verify the tubing and catheter have been properly cleared of air prior to inserting the catheter into the vasculature since entrapped can cause potential injury or fatality.

PRECAUTIONS

Appropriate DIP pads should be used to minimize skin burns. If the irrigation pump alarm sounds, terminate RF delivery. If impedance rises suddenly that does not exceed the preset limit, power delivery MUST be manually discontinued. Always maintain constant irrigation to prevent coagulation within and around electrodes. Irrigated ablation systems have been shown to create larger lesions than standard radiofrequency ablation catheters. Care should be taken when ablating near electrically vulnerable, thin-walled or other arterial structures. If irrigation is interrupted, immediately inspect and reflush the catheter outside of the patient. Reestablish irrigation flow prior to placing catheter in the body. Do not attempt ablation without using an irrigation pump.

POTENTIAL ADVERSE EVENTS

Potential adverse events include, but are not limited to, cardiovascular and anesthesia-related complications, including complete heart block requiring pacemaker. Please refer to the Instructions for Use for a complete list.

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies.

©2018 St. Jude Medical, Inc. All rights reserved.

SJM-CAG-0915-0035t(1)

Customer Support: 855-478-5833

Last Updated: March 29, 2018