ECA2302

Dénomination commerciale

non renseigné

26972011720131

B-26972011720131

Numéro de référence/catalogue

ECA2302

GS1

Classe IIa

Législation applicable

MDD [Directive 93/42/CEE relative aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

EndoClot® Adhesive is a sterilized single use medical device that is composed of Adhesive Hemostatic Polymer (AHP) particles and an applicator with a tube connecting to a clean external air source. AHP particles are biocompatible, non-pyrogenic and derived from synthetic polymer composed of polyethylene oxide (PEO) particles. The device contains no human or animal components. AHP particles are hydrophilic polymers that form an adhesive gel when in contact with blood or Gl fluids. The particles are delivered through a catheter inserted through the working channel of an endoscope which provides access to the bleeding site.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

• 2–2.2 MU24

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

• M040504INORGANIC HAEMOSTATIC DEVICES

2 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW999

  CONTRAINDICATIONS Do not use on patients with a known allergy to PEO. Do not use AHP particles for controlling surgery bleeding, only for gastrointestinal tract using. Do not inject AHP particles into blood vessels: extensive intravascular coagulation may occur. Do not inject AHP particles into the bile ductor pancreatic duct. Do not inject AHP particles into the bladder or ureteral lumen. Do not use AHP particles for controlling post-partum bleeding or menorrhagia. Do not use on patients suspected to have a bowel obstruction or ileus. Do not use the device in the vicinity of gastrointestinal anastomoses or gastrointestinal orifices such as gastrointestinal diverticula, the pancreatic duct, and the appendiceal orifice. EndoClot® Adhesive is contraindicated in patients who have gastrointestinal fistulas, are suspected of having a gastrointestinal perforation, or are at high risk of gastrointestinal perforation during endoscopic treatment.
• CW999

  WARNING EndoClot® Adhesive is not intended to use as a substitute for good endoscopic practice, and in particular, the proper use of conventional procedures for hemostasis. Ensure gastrointestinal lumen is not distended when EndoClot® Adhesive is used in the gastrointestinal tract as excessive luminal pressure may be generated by the gas source to cause bowel rupture and air embolism. EndoClot® Adhesive is designed for single use only. Attempts to reprocess, resterilize, and/or reuse may lead to device failure and/or transmission of disease. Use this device immediately after the package has been opened. Do not use if the package is opened or damaged when received. If any serious incidents related to the device occur, please report to the manufacturer and the local competent authority. PRECAUTIONS EndoClot® Adhesive is not recommended as a primary treatment for coagulation disorders. EndoClot® Adhesive is intended to be used in a dry state. Contact with fluids prior to application will result in the loss of hemostatic efficacy. All endoscopic hemostatic therapies, including EndoClot® Adhesive, have an associated risk of rebleeding, particularly in situations where the cause of bleeding is an unresolved underlying disease. After hemostasis has been achieved, monitor patients for rebleeding per the relevant Clinical Guidelines. Although not seen in clinical practice, there remains a theoretical risk of aspiration of AHP particles resulting in respiratory complications. It is prudent to restrict the use of EndoClot® Adhesive to 5 cm below the UES.