Symbols Glossary; Limits Of Liability - phenox pRESET Instrucciones De Uso

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ter + pRESET (LT) will SLOWLY be pulled back. Some resistance may be

observed at this point; the more distally the device has been introduced, the

more resistance might be encountered. Always pull gently, never abrupt or in

steps!

For the efficacy of the pRESET (LT) procedure in the posterior circulation,

the condition of the vertebral artery contralateral to the vessel catheterized

with the guiding catheter is important: If this artery is not supplying the basilar

artery, no further action is required. If this artery is fully patent, aspiration on

the guiding catheter will only affect the basilar artery when the non-cathete-

rized basilar artery is temporarily blocked. This may be achieved preferably

with a shape adaptive balloon catheter or by probing the A. vertebralis with a

diagnostic catheter having an occluding effect.

19. Follow under fluoroscopy as the device is travelling through the vessel under

aspiration. As soon as the pRESET (LT) has entered the guiding catheter,

withdraw can be accelerated. Pull the device in front of the RHV. Discon-

nect the RHV and the pRESET (LT) from the guiding catheter or aspiration

catheter. The aspiration started slowly with the pulling back of the pRESET

(LT), was increased from start to finish and has yielded one hundred to one

hundred and fifty (100-150) ml of blood up to this point. Aspirate for safety

reasons another fifty (50) ml of blood from the guiding catheter. As needed

close the guiding catheter e.g. using a syringe.

If applicable, deflate the balloon of the guide catheter acc. its IFU

20. Gently inject ten (10) ml of contrast medium into the guiding catheter to see

if the above described procedure restored vessel patency.

a) If the target vessel is patent, decide if further vessels are occluded and

need recanalization. If this is not the case, withdraw the guiding catheter,

wait for ten to fifteen (10-15) minutes and re-inject the concerning supra-

aortic vessel to confirm permanent patency.

b) If the target vessel is not patent, decide upon further action, which may in-

clude a repeated pRESET (LT) procedure, use of another mechanical device

or the attempt to use fibrinolytics.

21. In case of a repeated or an additional procedure an intact device can be

reused in the same patient.

1) Cleaning: Gently rinse the pRESET (LT) using sterile water or saline solu-

tion; blood or thrombus must not adhere to the device.

2) Inspection: Check the device to exclude any damage.

3) Preparation for new procedure: Push the proximal end of the insertion

wire into the corresponding tube (introducer sheath). Then move the tube

up to the device. Then pull the device SLOWLY and completely back in the

introducer sheath.

If the device cannot be pulled into the sheath it has to be discarded.

4) The reapplication of the pRESET (LT) follows steps 10 to 20 of this inst-

ructions for use.

Important Notes

▪ Before initial use never push the pRESET (LT) out of the introducer sheath

(transportation tube) in order to inspect it; pulling the device back would put

unnecessarily strain on the device.

▪ Copious flushing of the introducer sheath (transportation tube) is required to

remove potentially trapped air.

▪ Pushing the device beyond the tip of the microcatheter may dissect or perfora-

te the target vessel.

▪ Pulling or pushing on the insertion wire with inadequate force and torsion of

the insertion wire may disconnect the pRESET (LT) from the insertion wire. In

such cases the retrieval by a grasp device (Alligator Device) or snare device is

recommended.

▪ In case of excessive retraction resistance the reintroduction of the microcathe-

ter for splinting the pRESET (LT) insertion wire is recommended. If the micro-

catheter cannot be pushed completely over the device remove both, device

and microcatheter as a unit.

▪ Open the RHV of the guiding catheter completely before pulling the device out.

▪ If vasospasm is suspected in the affected vessel region, all necessary coun-

teractive measures (e.g. medication treatment) should be taken before the

pRESET (LT) treatment.

Precautions

▪ Use of the pRESET (LT) may entail a higher risk of vessel trauma and resultant

hemorrhage in patients with:

- an intracranial atherosclerotic vessel stenosis underlying the vascular occlusi-

on that is to be recanalized

- an intracranial vessel dissection underlying the vascular occlusion that is to be

recanalized

- intracranial vasospasm, e.g. following subarachnoid hemorrhage.

On the strength of past clinical experience the inherent risks of treatment with

pRESET (LT) are less in case of an underlying stenosis than in case of a diss-

ection or vasospasm. Particular care has to be taken on this occasion.

B 824 G pRE

IFU / 2016-05-04

SET

▪ The pRESET (LT) can be used up to three (3) times in the same patient. The

contact with the patient of all applications must in sum be less than 60 minu-

tes.

▪ Between the applications the device must be cleansed of blood and thrombus

and inspected for damages. If the device or the introducer sheath is damaged

or the device cannot be pulled into the introducer sheath it has to be discar-

ded!

▪ The device must not be resterilized or recycled for other patients because it

cannot be reliably cleaned.

▪ Use before date of expiry. Do not use damaged packages.

▪ Do not deploy the device in an artery smaller than the corresponding minimum

vessel diameter according to the table given in the compatibility charts.

▪ Apply the device under continous fluoroscopic monitoring.

▪ The pRESET (LT) is a delicate device and demands cautious treatment.

Do not advance or withdraw the device against resistance. Do not rotate the

insertion wire.

If necessary, remove pRESET (LT) via microcatheter.

▪ The device must only be used by specialised and trained physicians.

▪ The deployed pRESET (LT) must not be retracted through implanted vascular

implants!

Complications

The following and further complications may occur during or despite the appli-

ance of the pRESET (LT):

▪ Bleeding at the puncture site, nerve damage, allergic reaction, infection

▪ Air embolism, embolism in distal vessels, thrombosis and cerebral ischemia

▪ Vasospasm, formation of a pseudoaneurysm, intracranial hemorrhage

▪ Perforation, rupture, dissection and other arterial lesions

▪ Space-occupying infarction, neurologic deficit including symptons caused by

stroke

▪ Pain and hemiplegia, disorder of movement and/or sensation, death

Storage

Keep away from heat. Store in a cool, dry place.

Disposal

The device, retrieved clots, blood and if applicable its packaging have to be

disposed as biohazard waste.