Device Dossier

Pressure Injectable Arrowg+ard Blue Advance PICC pre-loaded with Arrow NaviCurve Stylet - Catheter, central venous, peripherally inserted

Device Dossier for Pressure Injectable Arrowg+ard Blue Advance PICC pre-loaded with Arrow NaviCurve Stylet - Catheter, central venous, peripherally…

Intended purpose

This kit contains a collection of sterile devices and materials intended to provide long term (>30 days) venous access to the central circulation. The Arrowg+ard Blue Advance (AGBA) technology (catheter coating) is intended to provide protection against microbial colonization and thrombus accumulation. The AGBA pressure injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the PI PICC may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate ranges from 4 mL/sec to 6 mL/sec. The Arrow Navicurve Stylet is intended for use with VPS Rhythm systems to provide PICC navigation using electromagnetic technology (VPS Rhythm DLX device supplied separately).

Functional description

The kit consists of a coated catheter along with ancillary components to assist in insertion and navigation. The Stylet is placed inside the catheter, an electromagnetic T-piece is placed on the patient sternum. ECG technology is used to track the location of the PICC. A line is displayed on the VPS Rhythm screen which shows the PICC pathway. As the catheter approaches the heart ECG waveforms are used to determine final catheter tip location.

TGA Public Summary