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It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure with an unknown smart touch bidirectional sf.The patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported that after an ablation procedure it was noticed that there was a post procedural injury: pericardial contusion.They did not have specifics on how it was discovered and confirmed.For medical intervention, a pericardiocentesis was performed.After completion, fluid was still seen in the patient, so a surgical window was opened to drain more fluid.The patient is now stable.There are no products available for return.The reported contusion (captured as soft tissue injury) led to the necessity of pericardiocentesis which is performed due to cardiac tamponade.On (b)(6) 2023, bwi was informed of the following: the lot number of the ablation catheter involved was unknown.The adverse event was discovered post use.(multiple days after initial procedure complication presented).Physician¿s opinion on the cause of this adverse event was unknown.Patient initially received a pericardiocentesis.Then patient had to have a surgical intervention to remove fluid from pericardial space (¿surgical window¿).Outcome of the adverse event was fully recovered.Generator information was a smart ablate; g4c-2982.A transeptal was performed but device details were lost.It was a baylis needle but unknown model.No pe or ct was noted.Patient discomfort and pericardial effusion was the presentation.There was no evidence of steam pop.The event occurred post procedure multiple days.Standard flow rates as per ifu.Was used for the irrigated catheter.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.Force visualization features used were dashboard; vector; visitag.Parameters for stability for the visitag module used was range of 1.5mm and time of 3 sec.No additional filter used with the visitag.Color options used prospectively was surpoint values.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.
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The device has been reported as discarded, therefore 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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