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It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered pneumonia which required prolonged hospitalization.It was reported that after pulmonary vein isolation (pvi), saturation decreased (50%) and the patient was foaming at the mouth.Based on the diagnosis, the patient was diagnosed with suspected aspiration pneumonia, which was probably caused by gastric juice entering the lungs.The patient was treated to restore saturation and then exited the room.Description of health hazard was suspected aspiration pneumonia.The physician assessment of the health problem was that no causal relationship with the product.There were no abnormalities observed prior to and during use of the product.The adverse event occurred on (b)(6) 2023.It was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that it was procedure or patient condition related.Not related to product.Intervention provided was aspiration of vomit and tracheal intubation was performed.The patient required extended hospitalization because of the adverse event as it was extended until the patient has recovered from the state worsened by low saturation.The patient fully recovered.Generator information was smartablate generator, model: m4900207, serial number: (b)(6).
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E 1.Initial reporter phone: +(b)(6).E 1.Initial reporter facility name (cont.): (b)(6) memorial hospital additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 31002442l number, and no non-conformances related to the complaint was found during the review.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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