| 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 |
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Event Type
Injury
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Manufacturer Narrative
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E1 initial reporter phone: (b)(6).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 reference number:(b)(4).
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Event Description
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It was reported that a patient underwent an atrial fibrillation ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac perforation that required surgical intervention.The physician suspected that the agilis sheath was responsible for the perforation/tamponade.Patient consequence: surgical intervention.The physician¿s opinion on the cause of this adverse event was the procedure.The outcome of the adverse event was patient fully recovered and / "chirugical intervention".The patient did not require any extended hospitalization.Transseptal puncture was performed.No ablation was performed prior to noting the pericardial effusion.No evidence of steam pop.The event occurred during the ablation phase.The flow was at 15 ml/s during ablation at 45w.The location of the perforation was the mitral isthmus and the patient required cardiac surgery.There were no error messages observed on biosense webster equipment during the procedure.A force problem had occurred as well but was resolved with a new cable.Although physician suspects agilis sheath, the bwi ablation catheter cannot be ruled out as a contributing factor to this adverse event as it occurred during the ablation phase.The medical team reported that no ablation was performed but also indicated that the perforation occurred during the ablation phase and identified a flow rate "during ablation at 45 w", which indicates that ablation was occurring at the time of the adverse event.The force issue is not captured on the ablation catheter as the cable was the culprit of that issue.
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Manufacturer Narrative
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On 20-mar-2024, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac perforation that required surgical intervention.The physician suspected that the agilis sheath was responsible for the perforation/tamponade.Patient consequence: surgical intervention.The physician¿s opinion on the cause of this adverse event was the procedure.The outcome of the adverse event was patient fully recovered and / "chirugical intervention".The patient did not require any extended hospitalization.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.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 number lot 31180019l and no internal action related to the complaint was found during the review.No malfunction was observed during the product analysis.The physician¿s opinion on the cause of this adverse event was the procedure.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 reference number: (b)(4).
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Manufacturer Narrative
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On 1-mar-2024, the bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Manufacturer's reference number: (b)(4).
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Search Alerts/Recalls
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