Abbott Agilis HisPro DS3H010-38, Instructions For Use Manual

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EN: English
Agilis HisPro
™
Steerable Catheter With Electrodes
Instructions for Use
Description
The Agilis HisPro
™
Steerable Catheter With Electrodes is a deflectable, slittable catheter with two distal tip electrodes. It serves as a
delivery conduit for devices such as cardiac leads. The distal portion can be formed into a “U” shape, when fully deflected, to
facilitate positioning of the tip at a desired location in the heart. The tip electrodes provide the ability to sense intracardiac
electrograms (EGM) and pace when connected to the WorkMate Claris
™
Recording System or the Merlin
™
Pacing System Analyzer
(PSA). The 10.5Fr catheter has a 7Fr inner diameter to allow delivery of a 6Fr cardiovascular transvenous device, including a 6Fr
pacing lead. The catheter shaft is slittable allowing for removal following lead placement.
Note: Safety and effectiveness of the Agilis HisPro catheter to deliver leads to the His Bundle has not been evaluated by the
FDA.
Table 1. Agilis HisPro
™
model
Model Effective Length Outer Diameter Inner Diameter
DS3H010-38 38cm 10.5Fr 7Fr
The catheter is compatible with the following Abbott Medical recording and pacing systems:
Table 2. Device Compatibility
System Device Connect via
WorkMate Claris
™
Recording System
Supreme Electrophysiology Cable (401980, 401981,
401982, or 401983)
Merlin
™
Pacing System Analyzer (PSA)
Supreme Electrophysiology Cable (401980, 401981,
401982, or 401983), Adapter Pins
Refer to the Merlin
™
PSA Help Manual for a complete list of cables required to connect the PSA to the Adapter Pins.
Indications for Use
The Agilis HisPro
™
Slittable Catheter With Electrodes is indicated to provide a pathway for delivery and support of transvenous
devices within the chambers and vasculature of the heart and can be used for electrogram recording and stimulation.
Contraindications
Crossing a mechanical tricuspid valve with this device is contraindicated.
Package Contents
The following accessories are included with the Agilis HisPro
™
Steerable Catheter With Electrodes.
Table 3. Package Contents
Accessory Intended Use
.035-inch guidewire Enables intravascular introduction of the dilator and Agilis HisPro Steerable Catheter With Electrodes.
Dilator Dilates the vasculature and facilitates access to vasculature.
Adaptor pins (2)
Connects to the Merlin ™ PSA via electrophysiology cable.
Valve bypass tool (2) Aids entry of devices through the hemostasis valve.
Slitter tool Slits the catheter for removal after delivery of the pacing lead.
Stopcock Facilitates aspiration and flushing.
Note: The guidewire material is PTFE coated type 304 stainless steel.
Complications
As with any catherization procedure, potential complications include thromboembolism, local and systemic infection, bleeding or
hematoma at the puncture site, vascular dissection or perforation, cardiac perforation, and cardiac tamponade.