E1 initial reporter phone: (b)(6).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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On 26-dec-2023, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported a patient underwent a cardiac ablation procedure which included the use of a thermocool smarttouch sf ablation catheter experienced that required management.The st rose during cti (cavotricuspid ishmus ablation).Coronary angiography confirmed spasm of right and left coronary arteries.Nitro coronary injection was performed and st normalized.No abnormal operation as a device.The patient's condition improved.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device 31122808l number, and no internal actions related to the reported complaint condition were identified.No malfunction was observed during the product analysis.The physician's opinion on the cause was the location of the coronary artery was close to the cti.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.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 reference number: (b)(4).
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