MANTA® Depth Locator - 14 French
INDICATIONS FOR USE: The MANTA Depth Locator (14F) is indicated for quantifying the depth of the femoral artery following the use of 10-14F devices or sheaths (12-18F OD) in endovascular catheterization procedures prior to 14F MANTA closure
CONTRAINDICATIONS: There are no known contraindications to the use of this device.
The MANTA Depth Locator (14F) is indicated for quantifying the depth of the femoral artery following the use of 10-14F devices or sheaths (12-18F OD) in endovascular catheterization procedures prior to 14F MANTA closure
WARNINGS: 1) Do not use with the 18F MANTA Vascular Closure Device or if the puncture site is >18F OD. 2) Do not use if the puncture site is proximal to the inguinal ligament or above the most inferior border of the epigastric artery (IEA), as this may result in retroperitoneal bleeding. 3) Do not use in patients with severe calcification of the access vessel. 4) Do not use if the target common femoral artery lumen is <5mm whether due to intrinsic vessel size or stenosis from any cause. 5) Do not use in the presence of an ipsilateral femoral or iliac artery stenosis resulting in >50% diameter reduction. 6) Do not use in patients with peripheral vascular disease, as evidenced by claudication when ambulating <100 feet, weak or absent pulses in the affected limb, or ABI <0.5 at rest. 7) Do not use if the package is damaged or any portion of the package has been previously opened. 8) Do not use if the items in the package appear damaged or defective in any way. 9) Do not REUSE or RESTERILIZE. The MANTA Depth Locator is single use only. Reuse or re-sterilization may cause degradation to the integrity of the device, leading to device failure which may result in patient injury, illness, or death. 10) Do not use the MANTA Depth Locator where bacterial contamination or infection of the target site is suspected. 11) Do not use if there is substantial bleeding around the Depth Locator at the access site during the Depth Location procedure, as this may result in an inaccurate measurement. 12) Do not use if the MANTA Depth Locator becomes kinked. 13) Do not use the MANTA Depth Locator if there has been a femoral artery puncture in same vessel within the prior 30 days, recent femoral artery puncture in same groin that has not healed appropriately, and/or recent (<30 days) vascular closure device placement in same femoral artery. 14) Do not use if the puncture site is at or distal to the bifurcation of the superficial femoral and profunda femoris artery. 15) Do not use if there is difficult dilation from initial femoral artery access (e.g., damaging or kinking dilators) while step dilating up to the large-bore device. Difficult dilation of the puncture tract due to scar tissue may lead to swelling of surrounding tissue, thus compromising the accuracy of the puncture depth determined during the depth location procedure. 16) Do not use if sheath insertion is in a vessel other than the femoral artery. 17) Do not use if there is marked tortuosity of the femoral or iliac artery. 18) Do not use if the patient has marked obesity or cachexia (BMI >40 kg/m2 or <20 kg/m2). 20) Do not use if the patient has post-procedure blood pressure >180 mmHg that cannot be lowered prior to access site closure. 19) Do not use if the patient has post-procedure blood pressure >180 mmHg that cannot be lowered prior to access site closure. 20) Do not use in patients who cannot be adequately anticoagulated for the procedure.
PRECAUTIONS: 1) The MANTA Depth Locator should only be used by a licensed physician or healthcare provider trained in the use of this device.
POTENTIAL ADVERSE EVENTS: The following potential adverse events related to the deployment of Vascular Closure Devices have been identified: 1) Ischemia of the leg or stenosis of the femoral artery. 2) Local trauma to the femoral or iliac artery wall, such as dissection. 3) Retroperitoneal bleeding, and its consequences, as a result of failed closure in the setting of an access above the inguinal ligament or the most inferior border of the epigastric artery (IEA). 4) Perforation of iliofemoral arteries, causing bleeding/hemorrhage. 5) Thrombosis formation or embolism. 6) Adjacent nerve damage or neuropathy. 7) Other access site complications leading to bleeding, hematoma, pseudoaneurysm, or arterio-venous fistula, possibly requiring blood transfusion, surgical repair, and/or endovascular intervention. Potential Adverse Events associated with any large bore intervention, including the use of the MANTA Vascular Closure Device, include but are not limited to: Arterial damage; Arterio-venous fistula; Bradycardia; Compartment syndrome; Death related to the procedure; Deep vein thrombosis; Ecchymosis; Edema; Infection at the puncture site which may require antibiotics or extended hospitalization; Inflammatory response; Late arterial bleeding; Oozing from the puncture site; Pressure in groin/access site region; Vessel laceration or trauma; Wound dehiscence.
MC-007697 - Rev 1. Revised: 03/2022.