BioProtect Balloon Implant System

Dénomination commerciale

BioProtect Balloon Implant System

07290014878013

7290014878BP0135V3

Numéro de référence/catalogue

0135

GS1

Classe III

Législation applicable

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

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

BioProtect Balloon Implant System

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

• V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER

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• Warnings: BioProtect Balloon Implant System should be used by physicians experienced with performing trans-perineal procedures under transrectal ultrasound guidance. User should be trained by a BioProtect representative. Do not use the BioProtect Balloon Implant System if the package was opened, broken or damaged, as sterility may have been compromised. Do not inflate prior to insertion. Do not use the BioProtect Balloon Implant System if the humidity indicator inside the package shows 40% or above (the 40% indicator is lavender color). Do not re-sterilize or reuse the BioProtect Balloon Implant System or any of its components. Do not use any part of the BioProtect Balloon Implant System after the indicated expiration date. If placing fiducials, do so with a transperineal approach prior to BioProtect Balloon Implant placement. Do not use the BioProtect Balloon Implant System if fiducials that were implanted with transrectal approach are in place.

  AUTRE

• BioProtect pivotal clinical trial demonstrated that the balloon is typically resorbed within 6 months, and residual risk of incomplete resorption showed no potential late complications or side effects. This residual risk is also supported by biological risk assessment and biocompatibility tests. During procedure Special care must be taken during dissection and balloon insertion to avoid perforation of adjacent organs and vessels or nerve damage. Pay attention to the UltraSound (US) monitor during insertion of the needle and dilator. Do not fill the balloon before it is located at the desired position. The saline solution should be 35-40°C (95-104°F) when filling the balloon. Do not overfill the balloon - the maximal amount of saline solution required to fill the balloon is 17ml. If you encounter difficulty filling the balloon in the proper space due to fibrosis, leave the balloon empty in situ. Post Procedure If subsequent infection, signs or symptoms of damage to adjacent organs is detected, the patient should be inspected and treated accordingly using modalities such as: patient reassurance, antibiotics, rectal examination, or balloon needle aspiration. Ensure safe disposal of needle and any used components and packaging materials utilizing standard hospital safety regulations and procedures and universal precautions for bio-hazard waste.