Catalog Number D134804 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Cardiac Perforation (2513)
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Event Date 02/09/2024 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent an atrial fibrillation ablation with a thermocool® smart touch® sf bi-directional navigation catheter and during ablation the patient experienced cardiac perforation that required surgical intervention.A pericardial effusion was identified after the anesthesiologist noticed that the patient's blood pressure dropped.The medical intervention provided was a pericardiocentesis.Patient was in stable condition.Physician¿s opinion on the cause of this adverse event was the procedure.The patient's condition is uncertain, the patient was taken to computed tomography (ct) surgery.The location of the perforation was the left atrium.Ablation was performed prior to noting the pericardial effusion.No evidence of steam pop.
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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.Manufacturer's reference number: (b)(4).
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Manufacturer Narrative
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On 12-mar-2024, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial fibrillation ablation with a thermocool® smart touch® sf bi-directional navigation catheter and during ablation the patient experienced cardiac perforation that required surgical intervention.A pericardial effusion was identified after the anesthesiologist noticed that the patient's blood pressure dropped.The medical intervention provided was a pericardiocentesis.Patient was 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 device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device 31020315l number, and no internal action related to the complaint was found during the review.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.Physician¿s opinion on the cause of this adverse event was 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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Search Alerts/Recalls
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