On (b)(6) 2024, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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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It was reported that a patient underwent a cardiac ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced pericardial effusion that required pericardiocentesis.The procedure started at 9:00 a.M., pericardial effusion was noticed after ablation at 1:00 p.M.After pericardial effusion procedure ended, the patient was successfully stabilized.There was no evidence of damage to the stsf force sensor during procedure or irregular irrigation.No map shift occurred.The carto 3 system worked well.Additional information was later received indicating the physician's opinion on the cause of this adverse event was procedure related or patient condition.The physician sees no fault in carto 3 system or bwi products.Medical intervention included fluid removed from the pericardium through puncture and drainage was placed.Transseptal puncture was performed.Ablation was performed prior to noting the pericardial effusion, no evidence of steam pop.No error messages observed on biosense webster equipment during the procedure.
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