Indications, Safety, and Warnings
Caution
Rx Only : Federal (USA) law restricts this device to sale by or on the order of a physician.
1. Do not use if the pouch is opened or damaged.
2. This device is intended for single use only. Do not reuse, reprocess, or re-sterilize. Reuse, reprocessing or re-sterilization may compromise the structural integrity of the device and/or lead to device failure, which may result in patient injury, illness, or death. Reuse, reprocessing, or re-sterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient.
3. After use, dispose of the device in accordance with hospital and/or local government policy.
Indications for use
The APRO® * 55 Intermediate Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems.
The APRO® * 55 Intermediate Catheter is also indicated for use as a conduit for retrieval devices.
Contraindications
There are no known contraindications.
Warnings
1. The APRO® * 55 Intermediate Catheter should only be used by physicians who have received appropriate training in interventional techniques.
2. The APRO® * 55 Intermediate Catheter is provided sterile and non- pyrogenic. Do not use if the packaging is breached or damaged.
3. Extreme caution should be used if it is required that the APRO® * 55 Intermediate Catheter be advanced near or through any aneurysms or other vascular malformations.
4. Do not wedge the tip of the APRO® * 55 Intermediate Catheter in the vessel, as this may result in perforation or dissection of the vessel wall.
5. Do not attempt to clear the inner lumen of the APRO® * 55 Intermediate Catheter by infusion while keeping the device in the patient. Remove the APRO® * 55 Intermediate Catheter from the patient before attempting to clear the lumen.
6. Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
7. For additional Materials of Concern information, such as REACH, CA Prop 65, or other product stewardship programs, go to www. medtronic.com/productstewardship.
Precautions
1. Do not use open, kinked, or damaged devices.
2. Do not autoclave.
3. Use the APRO® * 55 Intermediate Catheter in conjunction with fluoroscopic visualization.
4. Inspect the APRO® * 55 Intermediate Catheter before use to verify that its size and condition are suitable for the specific procedure.
5. Do not advance or withdraw the APRO® * 55 Intermediate Catheter against resistance without careful assessment of the cause using fluoroscopy. If the cause cannot be determined, withdraw the device. Moving or torquing the device against resistance may result in damage to the vessel or device.
6. Maintain a constant infusion of appropriate flush solution.
7. Extreme care must be taken to avoid damage to the vasculature through which the APRO® * 55 Intermediate Catheter passes. The APRO® * 55 Intermediate Catheter may occlude smaller vessels. Care must be taken to avoid complete blood flow blockage.
8. Torquing the APRO® * 55 Intermediate Catheter while kinked may cause damage that could result in possible separation along the catheter shaft. Should the APRO® * 55 Intermediate Catheter become severely kinked, withdraw the catheter along with the microcatheter, guidewire, and other devices being used.
9. An appropriate anticoagulation therapy should be applied per institutional guidelines.
10. Operators should take all necessary precautions to limit X- radiation dose to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors where possible.
11. Avoid excessive wiping of the coated device to ensure hydrophilic coating is not damaged and fiber particulate is not introduced onto the catheter.
12. The APRO® * 55 Intermediate Catheter was evaluated for compatibility with agents that include contrast media and heparinized saline. The use of these catheters for delivery of solutions other than the types that have been tested for compatibility has not been evaluated.
13. Carefully inspect all devices prior to use. Verify size, length, and condition are suitable for the specific procedure. Ensure the catheter's labeled outer diameter is smaller than the treatment vessel diameter.
14. Use prior to the "Use By" date specified on the product package.
15. Exercise care in handling the APRO® * 55 Intermediate Catheter to reduce the chance of accidental damage.
16. The presence of calcification, irregularities, or other devices may damage the APRO® * 55 Intermediate Catheter and potentially affect its insertion or removal.
17. If using a heparinized flush solution, ensure to account for the additional heparin being administered via the flush solution. Failure to do so could result in coagulopathy and excessive bleeding at the access site.
18. Do not use automated high-pressure contrast injection equipment with the APRO® * 55 Intermediate Catheter as it may damage the device and injure the patient.
19. The catheter distal shaft is hydrophilically coated. Make sure to hydrate the coating with heparinized saline before use. After the catheter is hydrated, do not allow it to dry.
20. Do not use if the labeling is incomplete or illegible.
Potential Adverse Events
Possible complications include, but are not limited to, the following:
Acute occlusion, Ischemia
Unstable angina
Arrhythmia, including ventricular fibrillation
Death
Distal embolization including to a previously uninvolved territory
Emboli
False aneurysm formation
Fever
Access Site Complications (hematoma or hemorrhage, sterile inflammation, granulomas)
Inflammation
Infection, Sepsis
Intracranial hemorrhage
Hypotension/Hypertension
Acute myocardial infarction
Infarction/Necrosis
Neurological defects, including stroke
Vessel spasm, thrombosis, dissection, perforation, rupture
Drug reactions (e.g., coagulopathy, renal insufficiency/failure, allergic reaction, and anaphylaxis from contrast media)
This device is required to be used with fluoroscopy. Potential complications related to angiographic and fluoroscopic X-ray radiation doses include, but are not limited to alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia. The probability of occurrence of complications may increase as procedure time and number of procedures increases.
Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.
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