background image

Instructions for Use

TorqVue

 LP Catheter

Summary of Contents for AMPLATZER TorqVue LP

Page 1: ... Instructions for Use TorqVue LP Catheter ...

Page 2: ...Inner diameter Outer diameter Length Usable length Recommended delivery sheath dimensions Do not use if package is damaged Manufacturer Catalog number Serial number Caution Federal law USA restricts this device to sale by or on the order of a physician Batch Code Use by date ...

Page 3: ...Date of manufacture Do not reuse Sterilized using ethylene oxide Unique device identification Quantity Follow instructions for use on this website Keep dry Catheter Contains phthalate Do not resterilize ...

Page 4: ...s valve Table 1 AMPLATZER TorqVue LP Catheter dimensions Fr mm in mm in cm 9 TVLPC4F90 080 4 1 17 0 046 1 40 0 055 80 Indications and Usage The AMPLATZER TorqVue LP Catheter is intended to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature Contraindications None known Warnings This device was sterilized ...

Page 5: ...rocedure using this device may include but are not limited to Air embolism Arrhythmia Arteriovenous fistulae Bleeding at the access site Brachial plexus injury Cardiac tamponade Death Dissection Embolism Endocarditis Hematoma Hemodynamic compromise Infection Myocardial infarction Perforation Peripheral pulse loss Stroke transient ischemic attack Thrombosis Valve damage Vascular access site injury ...

Page 6: ...structions for use supplied with the device 13 When the procedure is completed remove the delivery wire and the catheter WARNING Slowly remove the delivery catheter from the patient to prevent the introduction of air Disposal The instructions for use are recyclable Dispose of all packaging materials appropriately Dispose of device and accessories following standard solid biohazard waste procedures...

Page 7: ...ne North Plymouth MN 55442 USA 1 855 478 5833 1 651 756 5833 Indicates a trademark of the Abbott group of companies Indicates a third party trademark which is property of its respective owner Pat http www abbott com patents 2018 Abbott All Rights Reserved ...

Reviews: