Catalog Number D134805 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Cardiac Arrest (1762); Obstruction/Occlusion (2422); Ischemic Heart Disease (2493)
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Event Date 12/15/2023 |
Event Type
Injury
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Manufacturer Narrative
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Device investigation details: the device has been reported as discarded, 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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Event Description
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It was reported that a patient with ischemic heart issues and an implantable cardioverter defibrillator (icd) underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and patient experienced arterial occlusion, st segment elevation, cardiac arrest requiring surgical intervention and prolonged hospitalization.After ablating in the left ventricle for left premature ventricular contraction (pvc), while reprogramming the patient's bi-v icd and just prior to removing catheters, the patient's blood pressure dropped and st elevations were noticed on ekg.An interventional cardiologist was brought in, an angiogram performed under flouroscopy, confirming the occluded left main coronary artery.The patient given cardiopulmonary resuscitation (cpr), was cardioverted multiple times, eventually given a stent.Then the patient stabilized, blood pressure and ekg normalized, and they were transferred to the intensive care unit (icu) for observation and extended hospitalizaion.Patient fully recovered and was discharged.The physicians opinion was that it was likely not related to the ablation and the occlusion occurred from possibly plaque occluding the left main coronary artery.
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Search Alerts/Recalls
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