Catalog Number D134804 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Cardiac Tamponade (2226)
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Event Date 03/15/2024 |
Event Type
Injury
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Manufacturer Narrative
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Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31119741l and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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 a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced pericardial effusion that required pericardiocentesis.It was discovered during a standard post-procedure check using ultrasound.The pericardial effusion was confirmed using intracardiac echocardiography (ice).Medical intervention provided was a pericardiocentesis.The patient was reported to be in stable condition.The physician thought the injury may have occurred during catheter manipulation while placing the catheter in the right ventricular outflow tract (rvot).The physician's opinion on the cause of the adverse event was procedure; not product malfunction related.Patient fully recovered before patient left the room.Transseptal puncture was performed.Ablation was already performed prior to noting the pericardial effusion.No evidence of steam pop.The event occurred pepping phase in rvot.Ablation previously completed in left ventricle (lv).
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Manufacturer Narrative
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On 2-may-2024, 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.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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Manufacturer Narrative
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It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced pericardial effusion that required pericardiocentesis.It was discovered during a standard post-procedure check using ultrasound.The pericardial effusion was confirmed using intracardiac echocardiography (ice).Medical intervention provided was a pericardiocentesis.The patient was reported to be in stable condition.The physician thought the injury may have occurred during catheter manipulation while placing the catheter in the right ventricular outflow tract (rvot).The physician's opinion on the cause of the adverse event was procedure; not product malfunction related.Patient fully recovered before patient left the room.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.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 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.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 physician's opinion on the cause of the adverse event was procedure, not product malfunction related, no fault in carto 3 system or bwi products, the injury may have occurred during catheter manipulation while placing the catheter in the rvot.The patient was fully recovered before the patient left the room.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 ref.# (b)(4).
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Search Alerts/Recalls
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