Catalog Number D134805 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Cardiac Perforation (2513)
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Event Date 01/23/2024 |
Event Type
Injury
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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 ref (b)(4).
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Event Description
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It was reported that a patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac perforation that required pericardiocentesis and surgical intervention and prolonged hospitalization.The physician noticed a drop in blood pressure in the patient which resulted in the physician looking for an effusion when the perforation was discovered.Perforation was confirmed in the operating room.Medical intervention provided was a clipping of the left atrial appendage.The patient was reported to be in stable condition and was moved from the ep lab to the operating room and was in the intensive care unit (icu).Additional information was later received indicating the physician's opinion on the cause of this adverse event is that it was procedure or patient condition related.Intervention included pericardiocentesis and surgical intervention, clipping of left atrial appendage and the patient required extended hospitalization in order to recover from surgical intervention.Patient has improved.Other relevant history includes redo ablation.Transseptal puncture was performed.Ablation was performed prior to noting the pericardial effusion.No evidence of steam pop.No error messages observed on biosense webster equipment during the procedure.
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Manufacturer Narrative
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It was reported that a patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac perforation that required pericardiocentesis and surgical intervention and prolonged hospitalization.The physician noticed a drop in blood pressure in the patient which resulted in the physician looking for an effusion when the perforation was discovered.Perforation was confirmed in the operating room.Medical intervention provided was a clipping of the left atrial appendage.The patient was reported to be in stable condition and was moved from the ep lab to the operating room and was in the intensive care unit (icu).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 physician's opinion on the cause of this adverse event is procedure or patient condition.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 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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Manufacturer Narrative
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On 26-feb-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.Additionally, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.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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