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Shockwave IVL System with the Shockwave Javelin Peripheral IVL Catheter

Shockwave Medical, Inc. · Model JVNPIVLF · UDI-DI 00195451000799

PPN OEZ JAA Prescription

510(k) clearances

247

Adverse events (19 deaths)

Recalls

Facilities

Description

The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves; the shock waves modify calcified plaque in peripheral arteries. Energizing the intravascular lithotripsy device will generate acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion. The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter consists of three main components: the IVL Catheter, the IVL Generator, and the IVL Connector Cable. The Shockwave Javelin IVL Catheter is comprised of a catheter with an integrated emitter located near the distal end to enable the localized delivery of acoustic pressure pulses in the peripheral vasculature. The emitter is radiopaque to facilitate catheter visibility under fluoroscopy and is surrounded by a fluid-filled space (IVL window) that allows for the transmission of acoustic pressure pulses. The Shockwave Javelin Peripheral IVL Catheter shaft contains a lumen to pressurize and a lumen to de-pressurize the catheter with saline (the medium to create IVL), a guidewire lumen, and a lithotripsy emitter. The emitter is enclosed within a non-expandable polymer fluid-filled space (i.e., IVL window) containing saline that is connected to the proximal shaft, inlet and outlet ports, and is tapered down to the distal tip of the catheter. The IVL window is located near the distal tip of the catheter. The emitter is radiopaque to facilitate catheter visibility under fluoroscopy and is surrounded by the IVL window that allows for the transmission of acoustic pressure pulses. The IVL window is designed to provide a static catheter profile.

Recalls

Date	Firm	Reason
2018-07-18	Shockwave Medical, Inc.	Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.