F I S H
™
S
DEVICE P
FEMORAL INTRODUCER SHEATH & HEMOSTASIS
DEVICE
INSTRUCTIONS FOR USE
Read instructions before use.
Caution:
‘Federal law restricts this device for use by or on the order of a physician (or allied healthcare
professionals authorized by or under the direction of such physicians) who have been trained by an
authorized representative of MI, Inc. in the use of the FISH™ Device.”
CONTENTS:
907 W. Second Street, Bloomington, IN 47403 | 1-888-647-4465
SYSTEM COMPONENTS / DESCRIPTION
A.
Introducer Sheath with Closure Patch
The Femoral Introducer Sheath and Hemostasis Device (FISH™ Device) facilitates percutaneous entry of an
intravascular device and aids in reducing time to hemostasis and ambulation for femoral arterial access. French
sizes of the FISH™ Device indicated by color coding. Listed below are the two available French sizes and their
corresponding color.
FRENCH
COLOR
6 (2.0 mm)
Green
8 (2.7mm)
Orange
B.
Vessel Dilator
The vessel dilator atraumatically transitions the guide wire to the introducer sheath through a tapered tip, which
opens the tissue from the skin to the vessel below.
C.
Guide Wire
The guide wire is provided to maintain access to the vessel upon removal of an 18 or 21 gauge introducer needle
during the insertion of the FISH™ Device.
NOTE: The introducer needle is not included in the kit, so a sterile 18 or 21 gauge needs to be provided by the user
according to preference.
INDICATIONS
The Femoral Introducer Sheath and Hemostasis device (FISH™ Device) is intended for hemostatic closure of the
femoral artery access sites. The system is indicated for use in reducing time to hemostasis and time to
ambulation in patients who have undergone diagnostic procedures using 5, 6, 7, or 8 French procedural sheaths.
CONTRAINDICATIONS
This product should not be used in patients who have a known sensitivity or allergy to porcine derived material of
resorbable sutures.
WARNINGS
Do not use with Lipiodol contrast media, Ethiodal*, or contrast media that includes components of these agents.
Do not leave the FISH™ Device in the artery for prolonged periods of time (> 24 hrs.) without an obturator or
catheter assisting and supporting the cannula wall.
The FISH™ Device is for one use only. The function and/or performance of the device may be destroyed by
reusing, resterilizing, or cleaning the device. Additionally, adverse patient reactions may result. Morris
Innovative, Inc. will not be responsible for any damages or expenses that may result for reusing the
FISH™ device.
If the package of the FISH™ Device is damaged, stained, or appears tampered with/opened prior to use do not
use.
Do not autoclave. The introducer sheath and its components may be damaged by exposure to temperatures
above 54° C (130° F).
Do not expose device to organic solvents.
*Thiokol is a trademark of Guerbet S.A.
PRECAUTIONS
Prior to use, make sure the French size is correct for the catheter to be used.
When the FISH™ Device is used, the entire procedure should occur aseptically.
A power injector should not be used through the 3-way stopcock to the side tube.
Note expiration date on the device, and do not use the device if it is labeled as being expired.
Store FISH™ devices in a dark, cool, dry place. Avoid humidity and direct sunlight.
Use of the FISH™ System in diagnostic patients has not been evaluated in patients receiving glycoprotein
IIb/IIIa inhibitors.
Do not use the FISH™ Device if the puncture is made through the posterior wall of the femoral artery or if there
are multiple punctures as such punctures may result in a retroperitoneal hematoma.
Special Patient Populations
The safety and effectiveness of the FISH™ Device has not been established in the following patient populations:
Patients who are pregnant or lactating
Patients who are < 18 or > 80 years of age
Patients with bleeding diathesis or known hypercoagulable disorders
Patients with bleeding or platelet disorders
Patients having uncontrolled hypertension (systolic BP > 180mmHg)
Patients having auto-immune disorders
Patients having vascular grafts at the puncture site
Patients receiving glycoprotein IIb/IIIa inhibitors
Patients with: Pseudoaneurysm, AV fistula, intraluminal thrombus, or arterial dissection present in the
ipsilateral femoral artery prior to arterial closure
Patients having intra-procedural bleeding around access site
Patients having a palpable ipsilateral hematoma of any size observed during the catheterization procedure
Patients developing absent pedal pulses in the ipsilateral lower extremity during the catheterization procedure
Patients needing a procedure requiring an introducer sheath size of > 8F or < 4F
Patients having arterial closure site depth > 7.5cm
Patients having ACT > 400 seconds at the time of introducer sheath removal
Adverse Effects of the Device on Health
The FISH™ System was evaluated in a randomized controlled clinical investigation involving 206 diagnostic
patients enrolled at 8 United States clinical sites; 139 subjects (67%) received the FISH™ Device and 67 subjects
received (33%) the control, Manual Compression (MC). Prior to enrollment of randomized patients, each site
enrolled non-randomized roll-in patients for training purposes. There were a total of 19 roll-in patients in the
diagnostic study.
There was one (1) death reported during the randomized investigation, which was not device-related. This patient
was randomized to the FISH™ device.
Closure method related adverse events seen in the clinical study were:
Hematoma
Bleeding Requiring Transfusion
Pseudoaneurysm Requiring Thrombin Injection
Potential complications of allergic reaction, adhesion formation, infection or abscess, foreign body reaction,
wound dehiscence, or vessel occlusion were not seen. The following table (Table 1) shows the adverse events
from the diagnostic clinical study.
Introducer
Sheath with
Closure Patch
Vessel Dilator
Guide wire
