GlideLight Laser Sheath important safety information
The GlideLight Laser Sheath is intended for use with other lead extraction tools in patients who are suitable candidates for removal of implanted pacemaker and defibrillator leads. The use of the GlideLight Laser Sheath may be unsafe in some patients, or with certain leads, or when the leads cannot be extracted through the superior veins (that is, when groin or surgical extraction is required). Rarely a patient undergoing lead extraction may require urgent surgical treatment for a complication; therefore, patients should not undergo lead extraction with a laser sheath in centers where emergency surgical procedures cannot be performed. Leads not intended for extraction may be damaged during the procedure and may require replacement.
Potential minor adverse events associated with lead extraction procedures that may or may not require medical or surgical treatment include: a tear or damage to the blood vessels, the heart or its structures; bleeding at the surgical site; or collapsed lung.
Rare but serious adverse events that require emergency medical or surgical procedures may include: a tear or damage to the blood vessels, the heart, lungs or their structures; blood clot or obstruction of the blood vessels or lungs by debris or lead fragments. Other serious complications may include irregular heartbeat, weakened heart muscle, infection, respiratory failure, or complications associated with anesthesia, stroke, or death.
This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.
TightRail, TightRail Mini, TightRail Sub-C important safety information The TightRail, TightRail Mini, and TightRail Sub-C Rotating Dilator Sheaths are intended for use in patients requiring the percutaneous dilation of tissue to facilitate removal of cardiac leads. Rarely a patient undergoing lead extraction may require urgent surgical treatment for a complication; therefore, patients should not undergo lead extraction in centers where emergency surgical procedures cannot be performed. Leads not intended for extraction may be damaged during the procedure and may require replacement. Potential minor adverse events associated with lead extraction procedures that may or may not require medical or surgical treatment include: a tear or damage to the blood vessels, the heart or its structures; bleeding at the surgical site; or collapsed lung. Rare but serious adverse events that require emergency medical or surgical procedures may include: a tear or damage to the blood vessels, the heart, lungs or their structures; blood clot or obstruction of the blood vessels or lungs by debris or lead fragments. Other serious complications may include irregular heartbeat, weakened heart muscle, infection, respiratory failure, or complications associated with anesthesia, stroke, or death. This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you.
Bridge Plus Occlusion Balloon important safety information The Bridge Plus Occlusion Balloon is indicated for temporary vessel occlusion of the superior vena cava and inferior vena cava in applications including perioperative occlusion and emergency control of hemorrhage. Use of the Bridge Plus Occlusion Balloon in procedures other than those indicated is not recommended. The adverse events associated with an occlusion balloon procedure include, but are not limited to allergic reactions, death, embolization, hematoma, hemorrhage, sepsis/infection, short-term hemodynamic deterioration, thromboembolic episodes, vascular thrombosis, vessel dissection, vessel perforation, vessel spasm. Prior to initiating the procedure, a Bridge Plus Occlusion Balloon Catheter compatible guidewire should be placed through a venous access site and across the length of the superior or inferior vena cava. Attempting to place the guidewire after a tear has occurred may: Result in an inability to traverse the superior or inferior vena cava with the guidewire, Result in the guidewire exiting the vasculature at the tear site, Result in an inability to place the Bridge Plus Occlusion Balloon catheter or delay or prevent the ability to achieve occlusion
This information is not intended to replace a discussion with your healthcare provider on the benefits and risks of this procedure to you. Always read the label and follow the directions for use. Philips medical devices should only be used by physicians and teams trained in interventional techniques, including training in the use of this device. Products subject to country availability. Please contact your local sales representative. © Koninklijke Philips N.V. All rights reserved. Trademarks are the property of Koninklijke Philips N.V. or their respective owners. Philips reserves the right to change product specifications without prior notification.