BIOSENSE WEBSTER INC QDOT MICRO, BI, TC, D-F; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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Catalog Number D139505 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Laceration(s) of Esophagus (2398)
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Event Date 12/19/2022 |
Event Type
Death
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Event Description
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During a clinical trial, sponsored by biosense webster inc., was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a qdot-micro, bi-directional, d-f curve, c3, split handle catheter under general anesthesia.The patient experienced bloody, necrotic esophageal stenosis requiring surgical intervention.The patient ultimately passed away.On (b)(6) 2022, patient experienced bloody, necrotic esophageal stenosis categorized as severe and serious as defined by prolonged hospitalization from (b)(6) 2022 the patient ultimately passed away.Relationship to study device is not related and relationship to primary study procedure is causal relationship to the index procedure.The adverse event is unexpected/unanticipated.The outcome is fatal.Intervention was surgery, stenting.
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Manufacturer Narrative
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E1.Initial reporter phone: (b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30874958l number, and no internal action related to the complaint was found during the review.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.This report is being submitted late due to a retrospective review of complaints for the qdot micro products.Biosense webster¿s investigation determined that upon approval of qdot in the united states on november 23, 2022, the electronic complaints system was not updated and therefore medical device reports were not submitted in a timely manner.Through biosense webster¿s investigation it was determined that this was an isolated case.An internal action was opened to address this issue.Manufacturer's ref.No: (b)(4).
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Manufacturer Narrative
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On 25-mar-2024, an update was made to the clinical database.It was noted that there was no stenting done.The surgical intervention was removed from the treatment section.Therefore, the h 6.Health effect - impact code of ¿surgical intervention (f19)¿ was removed.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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