F01P1

Nom de l'organisation

Front Line Medical Technologies Inc.

SRN

CA-MF-000035504

Statut du fabricant

Actif

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• If resistance or an obstruction is encountered when advancing the device, remove the device and use an alternative means of treatment.

  AUTRE

• Do not exceed more than 10 balloon inflation/deflation cycles.

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• The balloon should be inflated slowly to avoid over inflation and should be deflated slowly to avoid patient hypotension.

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• The patient’s blood pressure should be monitored closely throughout the procedure.

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• Once temporary occlusion has been achieved, immediate measures should be taken for definitive care by a surgical team.

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• Incompatible avec la RM (MR Unsafe)

  The COBRA-OS® has not been tested for use with MRI (Magnetic Resonance Imaging). The patient should not receive an MRI exam while using the COBRA-OS®.

• Ne pas restériliser

  Do not reprocess or re-sterilize which may increase the risk of patient infection and/or affect the functionality of the device.

• Ne pas réutiliser

  The COBRA-OS® is a single use medical device for a single patient: as the device is contaminated with patient blood, its use on another patient can lead to blood group cross-reactions or transfer of potential blood borne infections.

• Ne pas utiliser si l’emballage est endommagé

  The package and device should be inspected prior to use to verify that no damage has occurred during shipment or storage. If the package or device is damaged, then do not use the device because sterility and/or device functionality may be compromised.

• Ne pas utiliser après la date indiquée

  Do not use the device after the expiration date on the label.

• Do not exceed maximum inflation volume (13 mL) and adhere to suggested volumes in Table 1. Over inflation may result in damage to the vessel wall, vessel rupture, balloon rupture, and/or air embolism. - Hand inflation using a 10 mL syringe is recommended to help prevent over inflation of the balloon when using larger volume syringes. - Do not use an inflation device to inflate the balloon, which may cause over inflation.

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• The COBRA-OS® must be purged of air, fully deflated, and the stopcock closed prior to inserting through the introducer sheath. Failure to do so may make it difficult to insert/advance the device and/or cause an air embolism if the balloon ruptures.

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• The COBRA-OS® must be fully deflated and stopcock closed prior to removing the device. Failure to do so may make it difficult/impossible to remove the device from the introducer sheath and/or vessel.

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• When attaching and detaching the syringe, hold on to the stopcock and not the overmolded hub. Holding on to the overmolded hub may cause the stopcock to separate from the device.

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• Do not use the COBRA-OS® for dilation of vascular grafts. Balloon rupture and/or damage to the vessel may occur.

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• Do not use the COBRA-OS® to perform valvuloplasty or angioplasty.

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• In pregnant patients, standard local guidelines for minimizing radiation exposure to the foetus should be used until the baby is delivered.

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• If available, use conventional x-ray or fluoroscopy to help confirm the position of the device and assist with balloon inflation and deflation. - Zone markers on the COBRA-OS® may be used to measure and track the depth of the device.

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• Use a recommended balloon inflation medium with appropriate concentration and dilution. Do not use air or gas to inflate balloon.

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• The COBRA-OS® is intended for temporary occlusion only. Longer term or permanent application of this device will cause major harm and/or death.

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• Training and experience in endovascular techniques is recommended for users of the COBRA-OS®.

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• Long occlusion times may cause major harm and/or death.

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• Do not modify the device or components in any way.

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• Care should be taken when using the COBRA-OS® in vessels with anatomic variability or otherwise diseased vessels.

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• The device should not be used in the treatment of dissection.

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Marché principal en Espagne ; disponible dans 12 pays au total.

Dénomination commerciale

non renseigné

Code d'IUD-ID

ID primaire

L'ID primaire est l'IUD-ID principal qu'un fabricant désigne comme identifiant de référence d'un dispositif dans EUDAMED.

10628678061054

IUD-ID de base

IUD-ID de base

L'IUD-ID de base est l'identifiant principal qui regroupe toutes les variantes d'un même modèle de dispositif — la clé de la « famille » réglementaire.

628678061001HJ

Numéro de référence/catalogue

F01P1

Entité d'attribution

Entités d'attribution IUD

Les entités d'attribution sont les organismes que la Commission européenne a désignés pour attribuer les identifiants uniques des dispositifs au titre du système IUD de l'UE.

GS1

Catégorie de risque

Classes de risque RDM

Les classes de risque du RDM classent les dispositifs médicaux du risque le plus faible (classe I) au plus élevé (classe III), ce qui détermine le niveau de contrôle réglementaire.

Classe III

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Occlusion temporaire de gros vaisseaux

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

• Numéro de lot
• Date d'expiration
• Date de fabrication
• Numéro de série
• Identification du logiciel

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• C019009AORTIC OCCLUSION SYSTEMS

• Dispositifs médicaux de Classe III dans EUDAMED

Santé des certificats sur le portefeuille de ce fabricant.