Indications For Use:
The MYNXGRIP? device is indicated for use to seal femoral arterial and femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath. Precautions:
The MYNXGRIP? device should only be used by a trained licensed physician or healthcare professional. The MYNXGRIP? device should not be used in patients with a known allergy to PEG. Warnings:
Do not use if components or packaging appear to be damaged or defective or if any portion of the packaging has been previously opened. DO NOT REUSE OR RESTERILIZE. The MYNXGRIP? device is for single use only. The balloon catheter is loaded with a single hydrogel sealant. Reuse of the device would result in no delivery of hydrogel sealant. Do not use the MYNXGRIP? device if the puncture site is located above the most inferior border of the inferior epigastric artery (IEA) (for arterial application) and/or above the inguinal ligament based upon osseus landmarks, since such a puncture site may result in a retroperitoneal hematoma/bleed. Perform a femoral angiogram or venogram to verify the location of the puncture site. Do not use the MYNXGRIP? device if the puncture is through the posterior wall or if there are multiple punctures, as such punctures may result in a retroperitoneal hematoma/bleed. Potential Adverse Events:
In addition to the complications noted in the MYNX? device clinical trial, the following potential complications, which may be related to the endovascular procedure or the vascular closure, may occur: allergic reaction, ecchymosis, superficial vein thrombosis, foreign body/local reaction, retroperitoneal bleed, vessel occlusion, pulmonary embolism, or death. See IFU for complete information.