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 31155602l number, and no internal action 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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During a clinical trial, it was reported that a patient underwent an index cardiac ablation for an atrial fibrillation (afib) and ischemic ventricular tachycardia on 23-nov-2023 with a qdot micro catheter.On 23-nov-2023, patient experienced worsening of a pre-existing condition ventricular fibrillation categorized as severe and serious defined by a serious deterioration in health with in-patient or prolonged hospitalization admission date of (b)(6) 2023 and discharge (b)(6) 2023.Relationship to study device is not related and relationship to primary study procedure is causal to the index procedure.The serious and procedure related event is categorized as expected/anticipated.The outcome is recovering/resolving.The intervention was cpr after cardioversion for fv during final testing and rosc (return of spontaneous circulation) within 2 minutes.
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