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 00001373 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.Manufacturer's reference number: (b)(4).
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During a clinical trial, sponsored by biosense webster, inc., it was reported that a (b)(6)male patient underwent an atrial fibrillation (afib) cardiac ablation procedure on (b)(6) 2020 with a carto vizigo¿ 8.5f bi-directional guiding sheath - small and suffered cardiac tamponade requiring pericardiocentesis.During the procedure a carto vizigo¿ 8.5f bi-directional guiding sheath - small was used.At some point of the procedure, cardiac tamponade was confirmed.Pericardiocentesis was performed to remove an unspecified amount of fluid from the pericardial space.Extended hospitalization was required as a result of the adverse event.Issue was resolved.Patient was discharged on (b)(6) 2020.The principal investigator assessed this event as severe, serious, possible related to the qdot micro¿ catheter, not related to the nmarq¿ multi-channel rf generator sw v3.0.1, not related to the nmarq¿ multi-channel rf generator sw v3.0.6, not related to the tx eco ext interface cable, not related to the tx eco cable dongle, not related to the bwi non-investigational devices (pump, tubing, cables, non-study catheters, etc) and causal index procedure related.In the opinion of the investigator, the adverse event was anticipated.No biosense webster, inc.Product malfunctions were reported.Since this event is related to a pre-market clinical study, it cannot be reported under the qdot catheter.Due to the implied relationship to the procedure, this event is being coded and reported under the carto vizigo¿ 8.5f bi-directional guiding sheath - small which is the listed marketed device used during the case.
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