Catalog Number D134805 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Cardiac Tamponade (2226)
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Event Date 02/05/2024 |
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 the patient experienced pericardial effusion that required pericardiocentesis.There was a baseline effusion of about 1 cm.The procedure was continued while the medical team was monitoring the effusion.At the end of the procedure, after cardioversion, the effusion had gotten bigger.Pericardiocentesis was performed and 500 cc of fluid was removed.The patient was stable throughout the entire procedure.Patient was transferred to icu.Patient improved after intervention.Transseptal puncture was performed.No evidence of steam pop.No errors were noted, and there was no indication of any abnormalities with carto.
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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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Manufacturer Narrative
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On 1-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 the patient experienced pericardial effusion that required pericardiocentesis.There was a baseline effusion of about 1 cm.The procedure was continued while the medical team was monitoring the effusion.At the end of the procedure, after cardioversion, the effusion had gotten bigger.Pericardiocentesis was performed and 500 cc of fluid was removed.The patient was stable throughout the entire procedure.Patient was transferred to icu.Patient improved after intervention.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 31191113l 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.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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Manufacturer Narrative
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On 8-apr-2024, bwi received additional information regarding the event.The catheter was confirmed to belong to the procedure.There was not a particular failure, but it had been in the patient¿s heart between the original baseline effusion note and the pericardial effusion was noticed at the end of the case.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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