Catalog Number D133604IL |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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.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 an unspecified ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and during the operation, the catheter was unable to deflect or relax completely.The knob couldn't be moved.There was difficulty in removing the catheter.There was no damage noted at the distal end.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 23-nov-2023, the product investigation was completed.It was reported that a patient underwent an unspecified ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and during the operation, the catheter was unable to deflect or relax completely.The knob couldn't be moved.There was difficulty in removing the catheter.There was no damage noted at the distal end.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.Visual inspection and deflection test of the returned device were performed following bwi procedures.Visual analysis revealed no deflection-stuck condition was observed.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.A manufacturing record evaluation was performed for the finished device 31109379m number, and no internal actions related to the reported complaint condition were identified.The deflection 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.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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