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Prostate and Bladder Biopsy

The removal of tissue samples from the prostate or bladder in order to diagnose to diagnose if a suspicious area is a benign (non-cancerous) or malignant (cancerous) disease.
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Prescriptive Information

Prescriptive Information

Indications

The TruPath biopsy device is indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.

Contraindications

  • Not indicated for use in sampling osseous tissue.

  • 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 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 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.

    This Product Contains No Detectable Latex.

    Potential Adverse Effects

    Although the TruPath biopsy device was engineered for optimal safety, there are potential adverse events associated with soft tissue sampling which may include:

  • A-V fistula formation

  • Biopsy-site pain

  • Bleeding

  • Edema

  • Fever

  • Gross hematuria

  • Hematoma

  • Hematospermia

  • Infection

  • Non-target organ laceration or laceration of other structures (nerves, vessels, etc.)

  • Non-target organ perforation or perforation of other structures (nerves, vessels, etc.)

  • Peritonitis

  • Pneumothorax

  • Sepsis

  • Vasovagal reaction


  • NOTE: There may be other side effects not identified.

    Cautions

  • Sharp instrument mishandling may cause accidental misfiring and/or potential needle stick to staff and/or patient.

  • The TruPath biopsy device is made from materials that are not compatible with MR (Magnetic Resonance) imaging magnets. Do not use in the MR suite.

  • WARNING: Test firing the needle without stabilization may damage the cannula tip. The needle may be stabilized if test firing is necessary by holding the cannula behind the tip between the thumb and fingers with moderate pressure.

  • CAUTION: Keep fingers or any other object behind the needle as itwill advance 22mm very rapidly when triggered. Never fire in an unsafe direction.

  • Do not leave the needle armed until ready to use.

  • This device is designed for single patient use only. Do not attempt to clean or resterilize this device for use on another patient.


  • Caution: Federal Law(USA) restricts these devices to sale by or on the order of a physician.


    Prescriptive Information

    Indications

    The Piranha Ureteroscopic Biopsy Forceps is intended for use in the collection of tissue endoscopically for histologic examination, such as the acquisition of neoplasmic tissue in the kidney and ureter.

    Contraindications

    When, in the judgement of the physician, open or endoscopic procedures would be contrary to the best interests of the patient; and for placing sutures into or through bone.

    Warnings

    For single use only. Do not reuse, reprocess or resterilize.

    Potential Adverse Effects

    The Potential Complications, which may result from an endoscopic access to collect biopsy samples include, but are not limited to tissue trauma and perforation, acute bleeding, injury to urinary tract.

    Cautions

    Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.




    Prescriptive Information

    Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

    Indications

    The Easy Core Biopsy Device is indicated for use endoscopically or percutaneously to retrieve tissue sampling of soft organs, tumors or masses for histological analysis. Soft tissue sampling includes, but is not limited to, organs such as breast, liver, kidney or prostate.

    Contraindications

  • Not indicated for use in sampling osseous tissue.
  • 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 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 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.

    This Product Contains No Detectable Latex.

    Potential Adverse Effects

    Although the Easy Core biopsy device was engineered for optimal safety, there are potential adverse events associated with soft tissue sampling which may include:

  • A-V fistula formation
  • Biopsy-site pain
  • Bleeding
  • Edema
  • Fever
  • Gross hematuria
  • Hematoma
  • Hematospermia
  • Infection
  • Non-target organ perforation or perforation of other structures (nerves, vessels, etc.)
  • Non-target organ laceration or laceration of other structures (nerves, vessels, etc.)
  • Peritonitis
  • Pneumothorax
  • Sepsis
  • Vasovagal reaction


  • NOTE: There may be other side effects not identified.

    Cautions

  • Sharp instrument mishandling may cause accidental misfiring and/or potential needle stick to staff and/or patient.
  • The Easy Core Biopsy Device is made from materials that are not compatible with MR (Magnetic Resonance) imaging magnets. Do not use in the MR suite.
  • WARNING: Test firing the needle without stabilization may damage the cannula tip. The needle may be stabilized if test firing is necessary by holding the cannula behind the tip between the thumb and fingers with moderate pressure.
  • CAUTION: Keep fingers or any other object behind the needle as it will advance 22 mm very rapidly when triggered. Never fire in an unsafe direction.
  • Do not leave the needle armed until ready to use.
  • This device is designed for single patient use only. Do not attempt to clean or resterilize this device for use on another patient.

  • Federal Law(USA) restricts these devices to sale by or on the order of a physician.