Amplatzer Torque Delivery System

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TorqVue™ 45° and 180° Delivery Systems

    https://manuals.sjm.com/~/media/manuals/product-manual-pdfs/f/c/fcba81dd-ae2f-46fb-9306-40d1418d6240.pdf
    delivery system by AMPLATZER™ device size, or refer to Table 3 to select the delivery system with a sheath that has the correct inner diameter as indicated in the device’s instructions for use. 2. Prepare the delivery system for use: - Inspect the sterile pouch and verify that it is unopened and undamaged. Do not use the components if the ...

Amplatzer™ Duct Occluders Abbott

    https://www.structuralheartsolutions.com/us/index.php?id=131&L=0
    AMPLATZER TM DUCT OCCLUDER AND DELIVERY SYSTEM INDICATIONS AND USAGE. The AMPLATZER TM Duct Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).. CONTRAINDICATIONS. Patients weighing less than 6 kg; Patients less than 6 months of age; Presence of thrombus at the intended site of implant, or …

TorqVue LP Delivery System - manuals.sjm.com

    https://manuals.sjm.com/~/media/manuals/product-manual-pdfs/e/8/e8f4a87e-3156-4e4f-a7f7-56374bcb6822.pdf
    The AMPLATZER™ TorqVue™ LP low-profile delivery system consists of a delivery catheter, loader, and hemostasis valve. Optional components of the AMPLATZER ™TorqVue LP delivery system are a delivery wire and plastic vise. The delivery system is designed to provide a pathway through which devices are introduced into the chambers and ...

Amplatzer PFO Occluder PFO Closure Device

    https://www.cardiovascular.abbott/us/en/hcp/products/structural-heart/amplatzer-pfo.html
    Amplatzer PFO Occluder is the industry’s leading patent foramen ovale (PFO) closure device with over 100,000 devices implanted worldwide. See clinical data.

MAUDE Adverse Event Report: AGA MEDICAL CORPORATION ...

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1380405
    The amplatzer torque delivery system (sheath and dilator) was received at aga medical. Visual inspection determined the distal half of the sheath did not have a …

St. Jude Medical Recalls Amplatzer TorqVue FX Delivery System

    https://www.dicardiology.com/content/st-jude-medical-recalls-amplatzer-torqvue-fx-delivery-system
    St. Jude Medical has issued a Class I recall for its Amplatzer TorqVue FX Delivery System used in transcatheter closure of atrial septal defects (ASDs). The company said in a small number of cases, the distal end of the core wire of the TorqVue FX system can fracture, which has the potential to cause serious adverse health consequences, including death.

Class 1 Device Recall AMPLATZER TorqVue FX Delivery System

    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=115439
    The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions. FDA Determined Cause 2: Device Design: Action: St. Jude Medical sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated January 18, 2013 to all affected customers.

TM Septal Occluder and Delivery System

    https://professional.sjm.com/~/media/pro/resources/ifu/amplatzer-us/sh-asd/600208-011_ASD_eIFU_Secure_amplatzer_septal_occluder_us.ashx
    Figure 2. AMPLATZER Delivery System. A. Loader – used to introduce the AMPLATZER Septal Occluder into the delivery sheath B. Hemostasis valve with extension tube and stopcock – allows flushing of the delivery system and controls back-bleeding C. Delivery sheath – provides a pathway through which a device is delivered

TorqVue 45° x 45° Delivery Sheath - professional.sjm.com

    https://professional.sjm.com/~/media/pro/resources/ifu/amplatzer-us/sh-ds/600274-002_TorqVue_45_x_45_eIFU_amplatzer_torqvue_45x45_us.ashx
    www.amplatzer.com Does not contain natural rubber latex components Device Description The AMPLATZER TorqVue Delivery Sheath is designed to provide a pathway through which a device may be delivered. The body of each sheath is radiopaque for visibility under fluoroscopy. The included dilator eases penetration of tissue. The 10 Fr,

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    http://www.tecnicasintervencionistas.com/instrumental/AMPLATZER%20TorqVue%20Delivery%20Systems%20Structural%20Heart%20Therapy.pdf
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