Model Number D134805 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Stenosis (2263)
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Event Date 08/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter phone: (b)(6).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 reference number: (b)(4).
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Event Description
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It was reported that an unknown patient underwent a left inferior pv (lipv) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered pulmonary vein stenosis after an ablation procedure.About 1 month after the procedure, the patient informed that they had breathing difficulty, so a ct was taken.Lipv was stenosed.The patient was cared for and has no symptoms now.The patient¿s clinical course is recovering/resolving.The physician's opinions on the relationship between the event and the product is that at the lipv ablation, the inside of pv was likely ablated with ablation catheter.No abnormalities were observed prior to or during use of the product.The product was used on (b)(6) 2022.The complaint occurred about a month after the procedure, around the end of august.This adverse event was discovered post use of the product.The physician¿s opinion on the cause of this adverse event is that it was due to the procedure.Intervention was provided but the details are unknown.The patient outcome of the adverse event is improved.The carto did not present any product problem.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.
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Manufacturer Narrative
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On 25-may-2023, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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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