Merit Medical ReSolve Manual Del Usuario página 12

I N S T R U C T I O N S F O R U S E
PROdUCT dESCRIPTION
The ReSolve Biliary Catheter with locking pigtail and hydrophilic coating is a multi-side holed, radiopaque catheter used for
percutaneous biliary drainage. The components of the catheter allow for introduction and placement using the over-the-
wire method.
The product may be packaged with the following components:
One (1) ReSolve Biliary Drainage Catheter with locking pigtail (A), hydrophilic coating and pigtail straightener (B)
drainage location: Standard or Long (G)
One (1) Metal stiffening cannula (C)
One (1) Flexible stiffening cannula (D)
One (1) Repositioning Tool (E)
One (1) Dead end cap (F)
INTENdEd USE OF PROdUCT
INdICaTIONS:
The ReSolve Biliary Drainage Catheter with locking pigtail and hydrophilic coating is used for drainage of bile within the
biliary system.
CONTRaINdICaTIONS:
The ReSolve Biliary Drainage Catheter is contraindicated for use where percutaneous biliary drainage catheterization is
unacceptable.
The ReSolve Biliary Drainage Catheter is contraindicated for intravascular use.
CaUTIONS
: Where long-term use is indicated, it is recommended that indwelling time not exceed 90 days. This catheter
should be evaluated by the physician on or before 90 days post-placement.
To maximize the advantages of the hydrophilic coating on the surface of the distal portion of the catheter, wet the catheter
prior to use with sterile water or saline. Keep catheter wet during placement.
WaRNINgS:
• RX Only Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
• Contents of unopened, undamaged package are sterile and non-pyrogenic
• This device is intended for single use only
• DO NOT wipe catheter with dry gauze or any solvents because it may damage the catheter coating
• DO NOT over tighten the connection between the drainage catheter and drainage tubing or dead end cap
• If using alcohol to clean the catheter hub, allow sufficient time for alcohol to dry before connecting the
drainage tubing or dead end cap
REUSE PRECaUTION STaTEMENT
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the
structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient
infection or crossinfection, including, but not limited to, the transmission of infectious disease(s) from one patient to an-
other. Contamination of the device may lead to injury, illness or death of the patient.
POTENTIal COMPlICaTIONS:
• Hemobilia
• Pneumothorax
• Sepsis
• Catheter leak
• Hemorrhage
• Perforation of the bile ducts, liver and/or duodenum
Biliary Catheter
• Cholangitis
• Hemothorax
• Biloma
• Catheter occlusion
• Bile peritonitis
• Pancreatitis
• Bilithorax
• Fever
• Catheter dislodgement
• Skin Infection
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