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 02/27/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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 ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and there was an intermittent or low irrigation on the device but not complete occlusion.No error message occurred.The issue was noted during device usage on the patient.The doctor found that the water output of the catheter was small and then worried about char, so they changed a new catheter.A second device was used to complete the operation.There was no adverse event reported on patient.
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Manufacturer Narrative
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On 3-apr-2024, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and there was an intermittent or low irrigation on the device but not complete occlusion.No error message occurred.The issue was noted during device usage on the patient.The doctor found that the water output of the catheter was small and then worried about char, so they changed a new catheter.A second device was used to complete the operation.There was no adverse event reported on patient.Device evaluation details: 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 number lot 31179932l and no internal action related to the complaint was found during the review.The irrigation 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.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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