Model Number D134805 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Stenosis (2263); Ischemic Heart Disease (2493)
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Event Date 11/28/2022 |
Event Type
Injury
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Manufacturer Narrative
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Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because 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.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 an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.A patient suffered a st elevation and coronary artery stenosis.Event was a coronary artery stenosis.There was st elevation after the procedure.Cag was performed, and stenosis in the left coronary artery was confirmed.Timing when complaints occurred was after completion of the procedure, before the patient leaving from the catheter¿s room.Medical treatment for stenosis was performed, and the patient left the room.The physician's opinion on the relationship between the event and the product was that since ablation was conducted in lcc for pvc, at that time, it may had been approached the vicinity of the lmt.There were no abnormalities observed prior to use and during use of the product.Additional information was received.It was discovered post use of biosense webster products.Physician¿s opinion on the cause of this adverse event was that it was procedure related.
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Manufacturer Narrative
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Additional information was received on 13-jan-2023.Intervention was not provided.Outcome of the adverse event was fully recovered.Generator was a smartablate generator.No abnormality about the generator.The lot number of the device is 30892433l.Therefore, processed the d10.Concomitant medical products and therapy dates to add the unk_smartablate generator.In addition, updated d4.Lot field, d4.Expiration date, and h4.Device manufacture date.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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Manufacturer Narrative
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The investigation was completed on 24-feb-2023.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 30892433l and no internal actions 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 reference number: (b)(4).
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Search Alerts/Recalls
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