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Can the Arrow Staple Anchoring Device be used in MRI? |
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The Arrow Staple Anchoring Device is made of 316 Low Carbon Vacuum Melted (LVM) stainless steel which is non-ferro-magnetic(1). The 316L series stainless steels are also used to manufacture the majority of cardiovascular stents(2).
The staple may induce alterations of the local magnetic field and lead to a loss of signal in the surrounding tissue(3).
(1) Abbott Ball. Stainless Steel. Physical Properties and Characteristics. Available at:
http://www.abbottball.com/products/steel.asp
(2) Shellock FG, Morisoli S, Kanal E. MR procedures and biomedical implants, materials and devices. Radiology 1993;189:587-599
(3) Jost C, Kumar V. Are current Cardiovascular stents MRI Safe? Available at:
See PubMed |
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Can we use the sideport of an indwelling sheath introducer to do blood draws? |
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Mechanically, sheath introducers are a single lumen system indicated for venous access. Clinicians should follow the same techniques as used with any CVC to maintain patency. If the catheter through the valve is withdrawn and the sheath introducer is left indwelling, an obturator must be used to guard against any potential bleeding or air embolism. |
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What is the function of the obturator on the Percutaneous Sheath Introducer products? Is there a danger to the patient if the obturator is not placed into the Introducer upon removal of an indwelling catheter? Are these obturators available separately? |
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The Hemostasis Valves in Arrow Percutaneous Sheath Introducers must be occluded at all times to minimize the risk of patient air embolism or hemorrhage. If catheter introduction is delayed, or the catheter is removed, temporarily cover valve opening with sterile-gloved finger until a catheter or obturator is inserted. Use an Arrow obturator, either included with the introducer or sold separately, as a dummy catheter with hemostasis valve/sideport assembly and sheath. This will ensure that leakage does not occur and the inner seal is protected from contamination. Two types of obturators are sold separately: Product # AO-07000 Arrow sheath obturator 5 1/2" (14cm) long and # AO-09000 Arrow Hemostasis Valve Short Obturator. Both are for use with Arrow 8.5 and 9.0 Fr Sheath Valve Assemblies. |
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Can we use a PSI or MAC with a power injector? What is the maximum pounds per square inch (psi) that can be injected through a Percutaneous Sheath Introducer (PSI) or Multi-Lumen Access Catheter (MAC™)? |
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No, non-pressure injectable catheters are not designed to withstand high pressures. Arrow tests every Percutaneous Sheath Introducer (PSI) and Multi-Lumen Access Catheter (MAC™) lumen to 15psi. This is done on every catheter to check for leaks in the introducer, interlumenal crossover and to verify that seals are functioning properly. This test is not meant to analyze the maximum strength of the catheter. Non-Pressure injectable catheters or sheaths are not designed to withstand the high pressures of power injectors. The maximum of 15psi or hand injections done with a 10cc or larger syringe are indicated. The use of an obturator cap is recommended. Consult the product labeling for additional information on the use of obturator caps.
The FDA's Center for Devices and Radiological Health has issued a Medical Device Safety reminder letter to radiologist, radiographic technologists, and radiological nurses and IV teams about the potential for serious patient injury when vascular access devices, not designed for pressure injection, are used for CT contrast media injections. Trying the same injections with a non-indicated catheter could result in a catheter failure and serious patient injury as documented by the FDA.
http://www.fda.gov/cdrh/medicaldevicesafety/tipsarticles/reminder-rvad.html |
