It was reported that a patient underwent a pvi ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and no water came out of the tip of the catheter during the procedure.During pvi, when a flush was performed at the time of changing the water back, no water came out of the tip of the catheter.The thermocool® smart touch® sf bi-directional navigation catheter was replaced with a new one.The procedure was completed without patient consequence.Additional information was received.No error was noted.The issue was discovered at the time of flushing after replacing a saline bag.The issue was resolved by replacing the catheter with another one.Correct catheter setting selected on the generator.The pump was switching from low to high flow during ablation.No occlusion related to char/clot/foreign material.
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E1.Initial reporter phone: (b)(6).Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 31137569l number, and no internal actions related to the complaint was found during the review.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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