| 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 03/06/2024 |
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Event Type
Injury
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Manufacturer Narrative
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The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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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Event Description
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It was reported that a patient underwent a redo atrial fibrillation / atrial flutter ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac perforation that required pericardiocentesis.While ablating on the left atrial lateral wall, under the appendage, a perforation occurred.There was no change in force or impedance during ablation.There was a drop in patient blood pressure.The effusion was discovered on intracardiac echo (ice).The patient received a pericardiocentesis, their blood pressure stabilized and they were stable.Also reported, prior to and unrelated to the patient complication, a force sensor error 106 occurred on the carto 3 system.The cable was exchanged without resolution.The thermocool® smart touch® sf bi-directional navigation catheter was exchanged and the issues resolved, case continued.Additional information was received.The physician's opinion on the cause of the adverse event is biosense webster, inc.Product malfunction, he claims the map shifted.This is untrue with picture evidence.Patient fully recovered.Patient spent an extra day in the hospital.Transseptal was performed with brk needle.Ablation was performed before pericardial effusion.No steam pop occurred.No error messages observed on biosense webster equipment during the procedure.The force sensor error was assessed as mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The adverse event was assessed as mdr reportable.
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Search Alerts/Recalls
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