Model Number D134702 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Cardiac Tamponade (2226)
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Event Date 11/10/2022 |
Event Type
Injury
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Manufacturer Narrative
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On 23-nov-2022, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 ref.# (b)(4).
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Event Description
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.It was reported by the bwi representative that while ablating on the roof of the left atrium, outside of the right superior vein the physician felt a steam pop occur.They stated that the physician checked for an effusion using intracardiac echo and transthoracic echo to confirm there was an effusion present.A pericardiocentesis was performed and 1620 ml of fluid was removed.The bwi representative did not know if the drainage tube was left in place at the time of the call.It was stated that the event occurred during the last ablation lesion, therefore, the procedure was completed.It was confirmed there was no additional intervention performed.The patient was stable during the procedure but could not confirm the current hemodynamic status of the patient during the call.Additional details include max wattage: 50w, total ablation time: 36 minutes, total fluid: 692 ml.
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Manufacturer Narrative
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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.It was reported by the bwi representative that while ablating on the roof of the left atrium, outside of the right superior vein the physician felt a steam pop occur.They stated that the physician checked for an effusion using intracardiac echo and transthoracic echo to confirm there was an effusion present.A pericardiocentesis was performed and 1620 ml of fluid was removed.The bwi representative did not know if the drainage tube was left in place at the time of the call.It was stated that the event occurred during the last ablation lesion, therefore, the procedure was completed device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed that no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, electrical, temperature and force features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.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.The root cause of the adverse event remains unknown.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 ref.# (b)(4).
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Search Alerts/Recalls
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