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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and after about forty (40) ablation cycles, thrombus was confirmed formed at the tip of the ablation catheter.Flushing was performed; however, the thrombus could not be removed.Therefore, the stsf catheter was replaced.The physician checked the ablation catheter because of high impedance.Some ablations exceeded 60 seconds per ablation but not greater than 120 seconds.The irrigation setting was within the recommended range.No error message observed.No adverse patient consequence was reported.
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E1.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: (b)(4).
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and after about forty (40) ablation cycles, thrombus was confirmed formed at the tip of the ablation catheter.Flushing was performed; however, the thrombus could not be removed.Therefore, the stsf catheter was replaced.The physician checked the ablation catheter because of high impedance.Some ablations exceeded 60 seconds per ablation but not greater than 120 seconds.The irrigation setting was within the recommended range.No error message observed.No adverse patient consequence was reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, temperature, impedance, irrigation, and patency test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.No char, thrombus or clot residues were observed during the inspection.The temperature and impedance test were performed, and the device was found working correctly.No temperature or impedance issues were observed.An irrigation and patency tests were performed, and the device was irrigating correctly.No irrigation issues or obstructed holes were observed.A manufacturing record evaluation was performed for the finished device number lot 31179869l, and no internal action related to the complaint was found during the review.The thrombus/clot issue reported by the customer was not confirmed.The impedance issue could not be replicated during the product investigation; therefore, was not confirmed.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instruction for use (ifu) contains the following warnings and precautions: before initiating the application of rf energy, a decrease in electrode temperature confirms the onset of saline irrigation of the ablation electrode.Monitoring the temperature from the electrode during the application of rf energy ensures that the irrigation flow rate is being maintained.Monitor the catheter tip temperature throughout the procedure to ensure adequate irrigation.If the temperature increases to 50°c during rf application, power delivery should be interrupted.Recheck the irrigation system prior to restarting the rf application.When rf current is interrupted for either a temperature or an impedance rise (the set limit is exceeded), the catheter should be removed, and the tip cleaned.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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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