Catalog Number D134805 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problems
Stenosis (2263); Thrombosis/Thrombus (4440); Heart Block (4444)
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Event Date 01/12/2024 |
Event Type
Injury
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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 and the patient experienced thrombosis, av (atrioventricular) heart block, and coronary artery stenosis requiring surgical intervention and extended hospitalization.Patient was treated for atrial fibrillation (af) ablation.During the procedure, an occlusion of the circumflex coronary artery is observed.Lengthening of the surface ecg (electrocardiogram) and then avb (atrioventricular blocks) values after radiofrequency shots in the left atrium.Radiofrequency in the coronary sinus to block the mitral line likely facilitated this circumflex occlusion.The coronary angiography on the table showed the clogging of the circumflex coronary artery.Resumption of the patient's natural rhythm occurred after drug injection of a vasodilator.This coronary was dominant on the right coronary, resulting in an inferior st+ acute coronary syndrome with complete "bav" (atrioventricular heart block).This st+ and the bav were amended as soon as the circumflex was reperfusion.This reperfusion, which occurs at 35 minutes from the onset of occlusion, follows the passage of the angioplasty guide and thromboaspiration.The injection of nitrates did not make it possible to modify the diameter of the stenosis observed at the time of reperfusion.Coronary stent placement immediately.Good patient constants were noted at the end of the procedure.The patient went on post-operative surveillance.4 days after surgery, the patient was doing well with preserved left ventricular ejection fraction.The gesture took place without technical difficulty.No abnormal catheter values were noted on the generator.After re-analysis of pre-procedure x-ray images, physicians were more inclined to believe that adverse events were related to the patient's anatomy.No device malfunctions were reported.
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Manufacturer Narrative
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The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.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 reference number: (b)(4).
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Manufacturer Narrative
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On 14-feb-2024, the product investigation was completed as the complaint device was not returned and the manufacturing record evaluation was provided.A manufacturing record evaluation was performed for the finished device number lot 31173800l 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 reference number: (b)(4).
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Search Alerts/Recalls
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