Catalog Number D134805 |
Device Problems
Device Contamination with Body Fluid (2317); Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 a supraventricular tachycardia (svt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and an irrigation tubing for the smarttouch catheter did not seat correctly to the catheter and the catheter tip became clotted off and would not irrigate.The catheter was replaced, and the procedure was continued and subsequently completed.No adverse patient consequence was reported.
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Manufacturer Narrative
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On 01-feb-2024, the product investigation was completed as no device was received.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device lot 31185798l and no internal action related to the complaint was found during the review.Additionally, the manufacture and expiration dates have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.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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