Catalog Number D134722IL |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1.Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation on 14-mar-2024.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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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Event Description
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It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf uni-directional navigation catheter and an irrigation issue with the device used on the patient occurred.Occlusion/ no irrigation.During the procedure, device (including port, luer hub) was not irrigating.A second device was used to complete the operation.There was no adverse event reported on patient.Additional information was received on 03-mar-2024.No error reported.Abnormal temperature increase at the catheter tip during ablation.Increasing the flow rate did solve the problem.Therefore, replaced the catheter immediately.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.This event was originally considered non-reportable, however, bwi became aware that the device was used on the patient with the irrigation issue on (b)(6) 2024 and have reassessed the event as reportable.
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Manufacturer Narrative
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It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf uni-directional navigation catheter.Occlusion/ no irrigation.During the procedure, device (including port, luer hub) was not irrigating.A second device was used to complete the operation.There was no adverse event reported on patient.Additional information was received.No error reported.Abnormal temperature increase at the catheter tip during ablation.The device evaluation was completed on 26-mar-2024.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and pump and pressure gage test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A pump and pressure gage test was performed, and the device was irrigating correctly.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue 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.The instructions for use contain the following recommendations: flush the catheter with heparinized saline prior to insertion into the body.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional information was received on 08-apr-2024 updating the facility information.Therefore, updated e.Initial reporter.E1.Initial reporter phone: (b)(6).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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Search Alerts/Recalls
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