BIOSENSE WEBSTER INC. LASSO NAV; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
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Model Number D134301 |
Device Problems
Device Operates Differently Than Expected (2913); Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/24/2018 |
Event Type
malfunction
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Event Description
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Ep lab reviewed.This was a mapping catheter and there were noises on the channel when the catheter was connected to the cable.The catheter was replaced.No injury to the patient.This is an ongoing issue with these catheters.Manufacturer response for lasso 2515, lasso 2515 (per site reporter).Bsw was alluding to problem being the cables not the devices.All cables were replaced in (b)(6).
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Search Alerts/Recalls
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