BIOSENSE WEBSTER INC QDOT-MICRO, BI-DIRECTIONAL, D-F CURVE, C3, SPLIT HANDLE.; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Catalog Number D139505 |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Pericarditis (4448)
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Event Date 09/13/2023 |
Event Type
Injury
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Manufacturer Narrative
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Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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 (afib) ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle.The patient experienced pericarditis post-procedure.The procedure date was (b)(6) 2023 and the reporting party was not made aware until (b)(6) 2023.There was no intervention for the pericarditis.Physician has not determined the cause.No intervention was provided for the issue.Pain meds were administered to the patient.The patient was kept overnight for observation.The patient fully recovered from the adverse event.No further information was provided.
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