Merit Medical Torpedo Instrucciones De Uso página 7

OPTION 2: TORPEDO DELIVERY WITH BLUNT STYLET
1. Attach the Torpedo to the hub of the delivery catheter that is positioned in the
vasculature for embolization.
Precaution: Only one (1) Torpedo should be delivered at a time. Delivering more
than one (1) Torpedo at a time may result in non-target embolization.
2. Using the blunt stylet, slowly push the gelatin foam Torpedo out of the cartridge and into
the delivery catheter.
3. Remove the empty Torpedo cartridge (with the blunt stylet still attached) from the
catheter hub.
4. Using a wet-to-wet connection, attach a 1 mL or 3 mL delivery syringe filled with 50:50
contrast/saline sterile mixture to the catheter hub.
5. Firmly depress the plunger on the delivery syringe to deliver the contrast/saline sterile
mixture and the Torpedo through the catheter and into the vasculature, observing the
delivery of the Torpedo under fluoroscopy. If the Torpedo does not exit after depleting
the entire volume of fluid in the delivery syringe, refill the delivery syringe with 50:50
contrast/saline sterile mixture and continue to delivery fluid until the Torpedo exits the
catheter.
6. If further embolization is desired, repeat steps 1-5 with additional Torpedoes.
7. Discard any empty Torpedo cartridges or unused devices, including the blunt stylet.
INFORMATION ON PACKAGING (SYMBOLS)
All serious or life-threatening adverse events or deaths associated with the use of
the Torpedo should be reported to the U.S. Food and Drug Administration under the
MedWatch program and to the device manufacturer. Information about the MedWatch
program and forms for reporting adverse events can be obtained at www.fda.gov/safety/
medwatch/howtoreport/ucm053074.htm or by calling toll free 888-463-6332. Reports to
Merit Medical, Inc. can be made by calling toll free 800-394-0295.
Manufacturer: Name and Address
Use By: YYYY-MM-DD
Lot Number
Catalog Number
Do Not Re-sterilize
Do Not Use if Package is Damaged
Keep away from sunlight
Keep dry
Single Use
Caution: Consult accompanying documents.
Read instructions prior to use.
Non-pyrogenic
Sterilized Irradiation