Model Number D134805 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
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Patient Problems
Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
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Event Date 11/17/2022 |
Event Type
Death
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Event Description
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It was reported that a patient underwent a ventricular tachycardia (vt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered hypotension, cardiac arrest and death.It was reported that during the vt procedure, the thermocool® smart touch® sf bi-directional navigation catheter was placed in right ventricular.The physician started ablation (35w, contact range 5-40g).Catheter was used as intended, with the correct settings.In 60 second of ablation, the physician noticed a steam pop.The physician interrupted ablation and checked patient parameters.The patient began to fail hemodynamically.Resuscitation and cardiac surgery did not help, patient was dead.During procedure, a biosense webster inc representative was not present.The physician does not raise any objections to the functioning of the biosense webster equipment.
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Manufacturer Narrative
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Device investigation details: available information indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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Search Alerts/Recalls
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