Manufacturer's ref.No: (b)(4).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.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.Biosense webster manufacturer's report numbers: 2029046-2021-00506 and 2029046-2021-00507 are related to the same incident.
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This complaint is from a literature source.The following complication was reported in this publication: it was reported that 1 patient underwent ventricular tachycardia (vt) ablation and suffered pericardial effusion.Intervention was pericardial drain.Model and catalog number are not available, but the suspected device is smart touch catheter.Other biosense webster devices that were also used in this study: pentaray , carto, pentaray nav.Non-biosense webster devices that were also used in this study: tacticath ablation catheter, ensite navx/velocity/precision (abbott medical, : livewire duodeca (abbott medical), advisor¿ hd grid mapping catheter (abbott medical), large curve agilis.Publication details: title: impact of a high-density grid catheter on long-term outcomes for structural heart disease ventricular tachycardia ablation.Objective: substrate mapping has highlighted the importance of targeting diastolic conduction channels and late potentials.During ventricular tachycardia (vt) ablation.State-of-the-art multipolar mapping catheters have enhanced mapping capabilities.The purpose of this study was to investigate whether long-term outcomes were improved with the use of a hd grid mapping.Catheter combining complementary mapping strategies in patients with structural heart disease vt.Methods: consecutive patients underwent vt ablation assigned to either hd grid, pentaray, duodeca, or point-by-point (pbyp) rf mapping catheters.Clinical endpoints included recurrent anti-tachycardia pacing (atp), appropriate shock, asymptomatic non-sustained vt, or all-cause death.
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