Super Sheath™ Introducer Sheath

Prescriptive Information

Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.

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Indications

This device is indicated for use in the introduction of diagnostic and interventional devices inserted into the human vasculature.

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Contraindications

none

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

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Potential Adverse Effects

• Air embolism
• hemorrhage (hematoma or retroperitoneal bleed)
• AV Fistula
• infection
• perforation of the vessel wall
• emboli
• intimal tear
• thrombus formation
• vessel occlusion
• pseudoaneurysm

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Cautions

This device is to only be used by a trained physician. The entire procedure shall be performed under aseptic conditions. Make sure the sheath size is appropriate for the access vessel and the diagnostic/ interventional devices to be used. Do not use opened or damaged packages. Use prior to "use by" date. Non-pyrogenic. Store in a dry, dark, cool place.

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Trademark

Super Sheath is a trademark of Medikit Co., Ltd.