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About Catheter Introducers
– A Potentially Life Threatening Episode
The Engage Introducer is used to
implant catheters and electrodes into blood vessels during surgery
and helps to prevent blood loss.
The tapered tip of the introducer is
inserted into an incision in a vessel. The catheter then easily
slides into the vessel by placing the catheter tip in the grooved
underside of the Introducer. The Introducer is then removed
allowing the catheter to be advanced to the desired position.
Some Engage Introducer devices have
the potential for separation of the shaft (sheath) from the hub or
for a break in the hub assembly. If either of these were to occur
during use, a potentially life threatening episode of bleeding
could occur.
ISO 11070 is the major introducer
and guide wire testing standard. Product leakage testing can help
determine the quality of an enclosure, connection, or seal in a
product or the integrity of packaging material. Leakage tests
generally involve leakage of air or liquid with internal or
external pressurization.
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