BIOSENSE WEBSTER INC QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Catalog Number D139505 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Cardiac Tamponade (2226)
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Event Date 11/13/2023 |
Event Type
Injury
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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 reference number: (b)(4).
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Event Description
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It was reported a patient underwent an atrial fibrillation (afib) cardiac ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle and patient experienced cardiac tamponade treated with a surgical intervention.It was reported that a transseptal was performed with a baylis needle and ablation was performed, there was a drop in blood pressure on the patient.No evidence of steam pop.The pericardial effusion was confirmed by ice (intracardiac echocardiography).The medical intervention provided was a pericardial window which was performed by a cardiovascular surgeon.The patient was reported to be in stable condition.Correct settings utilized on devices and no errors on the equipment during the procedure.Physician's opinion on the cause of the adverse event was the procedure.
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Manufacturer Narrative
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On 18-dec-2023, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 5-jan-2024, the product investigation was completed.It was reported a patient underwent an atrial fibrillation (afib) cardiac ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle and patient experienced cardiac tamponade treated with a surgical intervention.It was reported that a transseptal was performed with a baylis needle and ablation was performed, there was a drop in blood pressure on the patient.No evidence of steam pop.The pericardial effusion was confirmed by ice (intracardiac echocardiography).The medical intervention provided was a pericardial window which was performed by a cardiovascular surgeon.The patient was reported to be in stable condition.Device evaluation details: the device 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 force features were tested, and no errors were observed.The force values and the vector were observed within specifications.No force issues were observed.The other device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device 31154706l number, and no internal action related to the complaint was found during the review.No malfunction was observed during the product analysis, other issues or circumstances may have occurred during the usage of the device that compromised its performance.The root cause of the adverse event remains unknown.Physician's opinion the cause was the procedure.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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