Contraindications - Medtronic Cardioblate CryoFlex 60SF2 Mode D'emploi

Device Description
The Cardioblate
Probe (referred to as "the probe" throughout this
document) is a single use, disposable cryoablation
probe that is designed for use with the Cardioblate
CryoFlex™ Surgical Ablation System. The probe
has an integrated thermocouple for monitoring
temperature at its ablation segment. The probe
(shown below) is supplied sterile and cannot be
reused or resterilized.
Ablation segment is
the ribbed
portion of the shaft
The probe's shaft and ablation segment are made
of specially heat-treated stainless steel. The shaft
was designed with enough malleability that the
surgeon can easily shape it, while still maintaining
enough stiffness to ensure its stability in the
operating field.
The malleable ablation segment has a bellows
configuration, which provides kink resistance and
thermal performance. A movable insulated sleeve
on the shaft allows the surgeon to vary the size of
the ablation zone.
Ablation zones:
• Cardioblate
60SF3: 25 – 100 mm
• Cardioblate
0 – 70 mm
The probe has a 3 m (10 ft) connection hose
which is to be handed out of the sterile field to an
operating room nurse for connection to the control
panel.
Indications for Use
The Cardioblate
System is intended for minimally invasive cardiac
surgical procedures, including the treatment of
cardiac arrhythmias. The Cardioblate
7 cm, 10 cm, and 10-S probes plus the Clamp
and Surgical Ablation Console freeze target tissue
and block the electrical conduction pathways
by creating an inflammatory response and
cryonecrosis.
ML_3966-000_RevA.indd 2
Cardioblate
Instructions for Use - English
CryoFlex™ Surgical Ablation
®
White insulated sleeve
moves up and down the
shaft to adjust the size of
the freeze zone.
CryoFlex™ models 60SF2 and
®
CryoFlex™ model 60SF7:
®
CryoFlex™ Surgical Ablation
®
CryoFlex™
®
CryoFlex™ Surgical Ablation Probe
®

Contraindications

The Cardioblate CryoFlex™ Surgical Ablation
®
Probe is not designed for use inside a beating
heart.
®
Potential Adverse Events or
Complications
Potential adverse events with this device are
similar to other cardiac surgery procedures and
may include the following: bleeding; re-operation;
extension of extracorporeal bypass; heart rhythm
disturbances (atrial and/or ventricular); pericardial
effusion; pericarditis; cardiac tamponade; pleural
effusion; mediastinitis; conduction disturbances
(SA/AV node); acute ischemic myocardial event;
thrombus formation; low cardiac output; stroke;
renal, gastrointestinal or respiratory complications;
sepsis; adjacent structural damage; and death.
• Avoid contact between the cryoablation probe
and the phrenic nerve to avoid injury.
• Cryoablation involving coronary vessels has
been associated with subsequent clinically
significant arterial stenosis. It is unknown
whether cryoablation with the Cardioblate
CryoFlex™ Surgical Ablation Probe will have
such an effect, but as in all such procedures,
care should be taken to minimize unnecessary
contact with coronary vessels during
cryoablation.
Warnings
• Do not insert the Cardioblate
Surgical Ablation Probe inside a beating heart. If
a breach occurs in the probe inside a beating
heart, this may result in severe injury or death to
the patient.
• Do not pull on the Cardioblate
Surgical Ablation Probe or console while its
ablation segment is frozen to tissue as this could
lead to inadvertent tissue damage.
• Do not use excessive application force when
using the Cardioblate
Ablation Probe in order to avoid tissue damage.
• Surgical probe procedures may mechanically
induce arrhythmias.
• The Cardioblate CryoFlex™ Surgical Ablation
®
Probe should be positioned correctly and the
placement of the ablation segment confirmed
prior to cryoablation. Ensure that tissue adjacent
to the probe or below the targeted zone that is
not intended to be ablated is protected from
2
®
CryoFlex™
®
CryoFlex™
®
CryoFlex™ Surgical
®
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