Catalog Number D134805 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Paralysis (1997)
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Event Date 03/12/2024 |
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 diaphragmatic nerve paralysis, the patient will be followed-up.After the ablation for svci (superior vena cava isolation), right diaphragm elevation was confirmed by fluoroscopy.After the procedure, the right diaphragm elevation was continuously confirmed by fluoroscopy.The patient will be monitored for the symptoms.The physician's opinions on the relationship between the event and the product is that there was no relationship with the products.While svci, reaction was confirmed by crossing the svc electrode and the neural reflexes in the area crossed could not be confirmed.The patient will be followed-up.No abnormalities were observed prior to or during the use of the product.No surgical interventions were required.Patient has fully recovered.The patient did not require extended hospitalization.
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Manufacturer Narrative
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On 24-apr-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 an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced diaphragmatic nerve paralysis, the patient will be followed-up.After the ablation for svci (superior vena cava isolation), right diaphragm elevation was confirmed by fluoroscopy.After the procedure, the right diaphragm elevation was continuously confirmed by fluoroscopy.The patient will be monitored for the symptoms.The physician's opinions on the relationship between the event and the product is that there was no relationship with the products.While svci, reaction was confirmed by crossing the svc electrode and the neural reflexes in the area crossed could not be confirmed.The patient will be followed-up.No abnormalities were observed prior to or during the use of the product.No surgical interventions were required.Patient has fully recovered.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 this adverse event is that there is no relationship with the products.While svci, reaction was confirmed by crossing the svc electrode and the neural reflexes in the area crossed could not be confirmed.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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