Catalog Number D134801 |
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 12/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1 initial reporter phone: (b)(6).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.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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Event Description
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It was reported that a patient underwent a cardiac ablation procedure for atrial tachycardia (at) with a thermocool® smart touch® sf bi-directional navigation catheter.After the most premature site was ablated and induced, an additional ablation was to be performed, and a flush was performed prior to insertion.At that time, the physician noted that not all of the water was coming out of the irrigation hole.It was discovered at the time of flush before the additional ablation.No errors were noted on the pump or catheter.The catheter settings were correct.And the pump was functioning properly as well.The issue was resolved by replacing the smart touch sf catheter to another new one.The procedure was completed without patient's consequence.
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Manufacturer Narrative
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On 8-feb-2024, the product investigation was completed.It was reported that a patient underwent a cardiac ablation procedure for atrial tachycardia (at) with a thermocool® smart touch® sf bi-directional navigation catheter.After the most premature site was ablated and induced, an additional ablation was to be performed, and a flush was performed prior to insertion.At that time, the physician noted that not all of the water was coming out of the irrigation hole.It was discovered at the time of flush before the additional ablation.No errors were noted on the pump or catheter.The catheter settings were correct.And the pump was functioning properly as well.The issue was resolved by replacing the smart touch sf catheter to another new one.The procedure was completed without patient's consequence.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 31147391l number, and no internal actions related to the reported complaint condition 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.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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Manufacturer Narrative
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On 12-jan-2024, the bwi product analysis lab received the device for evaluation.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.Manufacturer's reference number: (b)(4).
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Search Alerts/Recalls
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