Hydra Jagwire® Guidewire

Prescriptive Information

Refer to the operator's manual for complete instructions for use.

Indications

The Hydra Jagwire guidewire is indicated for use in selective cannulation of the biliary ducts including, but not limited to the common bile, pancreatic, cystic, right and left hepatic ducts and to aid in the placement of diagnostic and therapeutic devices during bronchoscopic procedures.

Contraindications

No contraindications are known.

Warnings

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found call your Boston Scientific representative.

For single 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 cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Potential Adverse Effects

Use of guidewires in the gastrointestinal tract and the tracheobronchial tree may be associated with the following complications: infections, bleeding, breakage with retention of fragment, and/or perforation.

Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.

Cautions

Inappropriate use of the Hydra Jagwire guidewire may result in wire/tip breakage in the gastrointestinal tract or tracheobronchial tree.

Cautions can be found in the product labeling supplied with each device. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.