eXcelon® Transbronchial Aspiration Needle

Prescriptive Information

The eXcelon Transbronchial Aspiration Needle is indicated for use in aspiration in carinal, paratracheal, and hilar lesions of the bronchial tree where biopsy forceps cannot obtain a submucosal sample.

Contraindications

• This procedure should not be attempted in any patient whose general medical condition and degree of respiratory failure would not allow the patient to tolerate bronchoscopy (rigid or flexible) and/or the manipulation required to perform the procedure.
• Uncooperative patient.

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

Potential Adverse Effects that may occur include but are not limited to:

• Fever
• Transient bacteremia
• Pneumothorax
• Mediastinal infeciton
• Hemomediastinum
• Pneumomediastinum
• Minor bleeding

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

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.