Model Number BNI35BDH |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)
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Event Date 07/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30322200l 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.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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Event Description
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It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® sf nav bi-directional catheter and developed ventricular tachycardia (vt) and ventricular fibrillation (vfib) requiring external direct-current (dc) cardioversion.During ablation of the right ventricle outflow tract (rvot), the patient developed vt/vfib.External dc cardioversion was applied and returned to sinus rhythm.Treatment continued and patient¿s hemodynamics was stable upon leaving the room.There¿s no indication that extended hospitalization was required.Physician commented that the causal relationship between the adverse event and the biosense webster (bwi) product is unlikely.No biosense webster, inc.Product malfunctions nor error messages were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
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Manufacturer Narrative
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During an internal review on 11/2/2020, noted a correction to the 3500a initial as it was missing the 3500a ¿method code¿ of ¿analysis of production records¿.Therefore, populated this field.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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Manufacturer Narrative
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Additional information was received on 10/4/2020.The patient¿s gender is male.The patient¿s condition had improved.Therefore, updated a 3.Sex field.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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Search Alerts/Recalls
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