Model Number D134805 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter wherein the sterility of the catheter was compromised.Before using the device, the healthcare professional noticed that its packaging was not in its whole integrity.The catheter was not sterile.They used another device to complete the procedure.There was no patient consequence.
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Manufacturer Narrative
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This report is being submitted pursuant to the provisions of 21 cfr, part 4.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 ref.# (b)(4).
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Manufacturer Narrative
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It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter wherein the sterility of the catheter was compromised.Before using the device, the healthcare professional noticed that its packaging was not in its whole integrity.The catheter was not sterile.They used another device to complete the procedure.There was no patient consequence.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device number lot 30816720l and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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Manufacturer Narrative
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On 4-may-2023, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).
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Manufacturer Narrative
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It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter wherein the sterility of the catheter was compromised.Before using the device, the healthcare professional noticed that its packaging was not in its whole integrity.The catheter was not sterile.They used another device to complete the procedure.There was no patient consequence.Device investigation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The complaint was related to the package integrity being compromised; however, the package was not returned.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the complaint was found during the review.The customer complaint cannot be confirmed.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.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 ref.# (b)(4).
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Search Alerts/Recalls
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