Merit Medical Q50 PLUS, Instructions For Use Manual

QXMédical, LLC 

Document Part Number: 3064-001, Rev. 06 (10/2019) 

Page 3 of 76

Instructions For Use

1. DEVICE DESCRIPTION

The Stent Graft Balloon Catheter is designed for temporary 

occlusion of large vessels and to assist in the expansion of stent 

grafts used for the treatment of aortic aneurysms. Ballooning of a 

stent graft may improve modeling of the graft material and fixation 

of the stent graft to the vessel wall. Sub-optimal expansion of stent 

grafts may also be improved by inflating the balloon at the site 

of the stent. The Stent Graft Balloon Catheter has been tested to 

temporarily occlude vessels up to 41 mm in diameter.
The Stent Graft Balloon Catheter is an over-the-wire (OTW) tri-

lumen catheter with a compliant polyurethane balloon having 

a maximum diameter of 50 mm at 60 cc. Two lumens inflate and 

deflate the balloon while one lumen is reserved for guidewire 

passage. The catheter is offered in two (2) usable lengths, 100 cm 

and 65 cm.
This device is designed to accommodate a 0.038” diameter (or 

smaller) guidewire. Two (2) radiopaque marker bands are placed 

within the balloon at each end [40 mm apart] to facilitate balloon 

placement prior to inflation. The catheter can accommodate a 

0.038” diameter (or smaller) guidewire and is compatible with 10 Fr 

(or larger) introducer sheaths. The catheter has an extension tube 

with a stopcock in order to facilitate handling and fluid control. The 

device models are listed below:

Catalogue Number

Catheter Effective Length

Q50-65-X

65 cm

Q50-100-X

100 cm

There are risks involved with any medical procedure. Both physician 

and patient should fully understand those risks associated with 

surgery, and additional new risks associated specifically with the 

use of this endoluminal device.

CAUTION: Only physicians trained in vascular surgery, 

interventional radiology or cardiology, and who have 

completed training or have experience with stent grafts, 

balloon catheters and associated devices should consider 

using this device. 
CAUTION: Read the entire Instructions for Use manual prior to 

using the device.

8 Fr (2.70 mm)

10 Fr (3.33 mm) Minimum Sheath Diameter

1.97" (50 mm) Maximum Balloon Diameter

0.038" (0.97 mm)

Maximum Guidewire 

Diameter

40 mm

65 cm OR 100 cm

Q50

®

 X 

STENT GRAFT

 BALLOON CATHETER

2. INDICATIONS FOR USE

The Stent Graft Balloon Catheter is intended for temporary 

occlusion of large vessels or to expand vascular prostheses.

3. CONTRAINDICATIONS

The Stent Graft Balloon Catheter is contraindicated in patients 

who:

•  Are contraindicated to contrast media or anticoagulants
•  Have an arterial entry site that cannot accommodate a 10 Fr 

(min) introducer sheath

•  Are minors <18 years old
•  Are pregnant

4. WARNINGS

•  The Stent Graft Balloon Catheter is supplied STERILE and for 

single use only. Do not reprocess or re-sterilize. Reprocessing 

and re-sterilizing could increase the risk of patient infection 

and of compromised device performance.

•  The catheter should only be manipulated and inflated/deflated 

while observing under fluoroscopy.

•  If resistance is encountered at any time during the insertion 

procedure, do not force passage or torque the catheter. 

Resistance may cause damage to device, vessel or stent graft. 

Carefully withdraw the catheter.

• Do not torque or twist the catheter during insertion or 

withdrawal.

•  The catheter should only be advanced or withdrawn over a 

guidewire.

• Adhere to balloon inflation parameters outlined in the 

Balloon Compliance Chart (Table 1)

. Do not exceed a balloon 

diameter of 50 mm and do not exceed 60 cc inflation volume at 

50 mm balloon diameter. Rupture of balloon may occur. Over-

inflation may result in damage to vessel wall and/or vessel 

rupture, or damage to the stent graft.

•  Balloon rupture may occur under certain anatomical, procedural, 

and/or clinical circumstances. It is therefore recommended to 

have back-up Stent Graft Balloon Catheters on hand.

•  Ensure that the balloon is fully deflated before moving the 

Stent Graft Balloon Catheter.

•  When expanding a vascular prosthesis, there is an increased 

risk of vessel injury and/or rupture, and possible patient death, 

if the balloon inflation is not completely within the covered 

(graft fabric) portion of the prostheses.

• Studies indicate that the danger of micro-embolization 

increases with increased manipulation and/or duration of the 

procedure.

•  Over inflation of the balloon can cause graft tears and/or vessel 

rupture. Care should be taken when inflating the balloon in