MEDTRONIC, INC. ARCTIC FRONT ADVANCE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Model Number 2AF284 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/26/2017 |
Event Type
malfunction
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Event Description
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During atrial fibrillation (a-fib) ablation in the electrophysiology (ep) lab, the balloon ruptured during final inflation.Balloon had been inflated/deflated numerous times during the procedure.
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Search Alerts/Recalls
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