| 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 01/18/2024 |
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Event Type
Injury
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Event Description
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It was reported that a patient underwent an atrial fibrilaltion ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac perforation that required protamine and prolonged hospitalization.While ablating the left atrium of the heart, they had high-force readings while on the posterior wall.The caller reported that when they tried to move the catheter, the force vector was acting oddly.The physician thought he was in the pericardial space, and a perforation was discovered.The patient had a small effusion that was confirmed on the x-ray and intracardiac echocardiography (ice).The patient exhibited no abnormal symptoms.They pulled the catheter out of the patient and gave the patient protamine.No further medical intervention was performed but patient was transferred to intensive care unit (icu).The case was discontinued.The patient was stable.Additional information was later received indicating the physician¿s opinion on the cause of the adverse event is that it was procedure related.The patient was reported to be fully recovered but stayed in the icu overnight.Ablation was performed prior to noting the pericardial effusion.No evidence of steam pop.No error messages observed.
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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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Manufacturer Narrative
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On (b)(6) 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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Manufacturer Narrative
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On 19-feb-2024, additional information was received indicating the force vector was pointing inward toward the left atrium when they thought it was on the posterior wall, indicating that they were actually in the pericardial space.This is what they meant when the previously reported ¿the force vector was acting oddly.¿ 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 non-conformances 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.Physician¿s opinion on the cause of this adverse event was procedure.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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