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Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the 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 reference number: (b)(4).
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It was reported that a 56-year-old female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.The patient suffered hematoma and pericardial effusion.It was reported that during an afib case, the patient suffered a pericardial effusion and a septal hematoma during the attempt at gaining transseptal access.The patient experienced symptoms of bradycardia and hypotension throughout the procedure.They had to pace in order to keep the patient's blood pressure up.They were unsure if the patient's symptoms were related to the pericardial effusion or to the anesthesia.The pericardial effusion was discovered with intracardiac echocardiography (ice) and confirmed with a 2d echocardiogram.The procedure was aborted.The medical intervention provided was a temporary pacemaker.The patient was sent to icu and no pericardiocentesis was performed.The patient was reported to be in stable condition.The physician was unable to confirm that the pericardial effusion was not preexisting, and that the physician was unsure of what caused the injury.It was reported that there had been multiple attempts at going transseptal.They reported multiple rf attempts with the needle at going transseptal.It was uncertain whether the injury was wire, needle, or sheath related.The pericardial effusion was discovered after the vizigo sheath was pulled out of the body, and the decanav catheter and the ice catheter were the only bwi products inside the patient.Bwi company representative stated that there were two attempts at going transseptal where the wire went across but the vizigo sheath was unable to get across.They attempted to go transseptal with rf, then they attempted to push the ablation catheter across a patent foramen ovale (pfo) and were unable to get across, then attempted to go transseptal in a new spot in the septum, then attempted to go transseptal with rf again.They replaced the vizigo sheath with the sl1 sheath and the injury was discovered before attempting to go transseptal with the sl1 sheath.The specific date the adverse event occurred was on (b)(6) 2022.The adverse event was discovered after vizigo sheath was exchanged.Decanav and soundstar were still in use.Physician said it could be the procedure or patient condition that caused he adverse events.Intervention provided was temporary pacemaker and adjustment in anesthesia medication.The outcome of the adverse event was unchanged (dr.Believes the effusion was not produced by this procedure when they followed up with him on 14-nov-2022).Patient was observed overnight, and they believe the patient was discharged the following day.Generator was not used in procedure.Product name, lot number of the ablation catheter involved was product #(b)(4), lot # n/a.Device is not available to return.Lot number and product code of the ice catheter involved was product #10439236, lot # n/a.Baylis nrg needle was used for the transseptal puncture performed.There was no evidence of steam pop.The event occurred during the transseptal phase.The flow setting for the irrigated catheter used was low flow.No ablation was performed.No unusual error messages observed on biosense webster equipment during the procedure.Visitag module not used.No damage observed on sheath/dilator due to the obstructed sheath.No occlusion observed when irrigating the sheath.No resistance observed or noted between devices or against vasculature.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.Biosense webster manufacturer's reference number (b)(4) has 2 reports.This report is for the thermocool smarttouch.The vizigo sheath was submitted in another report.
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