Catalog Number D134805 |
Device Problem
Contamination /Decontamination Problem (2895)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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 ref.(b)(4).
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Event Description
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the tip was covered by a white film.It was reported that the catheter was taken out of the patient and the tip was covered by a white film.It was replaced and the case continued.There was no patient consequence.
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Manufacturer Narrative
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On 3-apr-2024, 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.Additionally, the manufactured date and expiration date 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 ref.# (b)(4).
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Manufacturer Narrative
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the tip was covered by a white film.It was reported that the catheter was taken out of the patient and the tip was covered by a white film.It was replaced and the case continued.There was no patient consequence.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual inspection of the returned sample revealed that a white film material was covering the dome section.For this reason, a fourier-transform infrared spectroscopy (ftir) analysis was requested, and it was concluded that foreign material is primarily composed of a biological base material presumably tissue.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The foreign material issue reported by the customer was confirmed.The potential cause of the tissue attached to the dome cannot be determined, it could be related to the usage of the device during the procedure; however, this cannot be conclusively determined.The instructions for use (ifu) contain the following recommendations: always maintain a constant heparinized normal saline infusion to prevent coagulation within the lumen of the catheter.Do not use the catheter without irrigation flow.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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