Catalog Number D134721IL |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/12/2023 |
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 atrial fibrillation (afib) - paroxysmal ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and during the operation, the catheter was unable to deflect or relax completely.The catheter was completely stuck in a full deflected position.There was no difficulty in removing the 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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23-nov-2023, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation (afib) - paroxysmal ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and during the operation, the catheter was unable to deflect or relax completely.The catheter was completely stuck in a full deflected position.There was no difficulty in removing the 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 deflection test of the returned device were performed following bwi procedures.Visual analysis revealed several kink along the shaft, no other damage was observed.The damage observed could be related to the manipulation of the device during the procedure, however, this can not be conclusively determined.A deflection test was performed, and despite the kink along the shaft, the curve was deflection within specifications.No deflection issues were observed.A manufacturing record evaluation was performed for the finished device number lot 31029815l and no internal actions related to the complaint were found during the review.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.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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