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E 1.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 the tubular part of the irrigation port attached to the handle was kinked and could not irrigate.During the case, ablation was stopped when the temperature rose high.When the irrigation was checked outside the patient's body to see if it was working properly, it was discovered that the irrigation was inadequate.There was no error noted.Correct catheter settings were selected.The issue was resolved by replacing the stsf catheter to a new one.After that, the procedure was successfully completed without patient consequence.The issue with the tubular part of the irrigation port as well as the issue with high temperature were both assessed as not mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The irrigation issue is mdr reportable.
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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 the tubular part of the irrigation port attached to the handle was kinked and could not irrigate.During the case, ablation was stopped when the temperature rose high.When the irrigation was checked outside the patient's body to see if it was working properly, it was discovered that the irrigation was inadequate.There was no error noted.Correct catheter settings were selected.The issue was resolved by replacing the stsf catheter to a new one.After that, the procedure was successfully completed without patient consequence.The issue with the tubular part of the irrigation port as well as the issue with high temperature were both assessed as not mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, temperature, impedance, pump, and pressure gage test of the returned device were performed following bwi procedures.Visual analysis revealed no damage nor anomalies on the luer hub.The temperature, impedance, pump, and pressure gage test were performed, and the device was found working correctly.No temperature, impedance or irrigation issues were observed.A manufacturing record evaluation was performed for the finished device number lot 31156574l and no internal action related to the complaint was found during the review.Additionally, the manufacture and expiration dates have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.The luer hub, irrigation issue, and temperature issues reported by the customer could not be replicated during the product investigation.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.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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