Patient history: a female patient ((b)(6) was treated on (b)(6) 2019.The patient's history included a previous ablation in 2013 to treat the patient's atrial fibrillation (af).The patient was cardioverted in (b)(6) 2018.Description of the event: on (b)(6) 2019, a serious adverse event (ae) was reported during the acutus clinical study (recover af).It was reported that post procedure the patient developed hypotension and a drop in blood pressure.A ct scan showed a small arteriovenous fistula in the groin.There was no evidence of retroperitoneal bleeding.The drop in blood pressure was viewed to be external bleeding from a sheath removal rather than internally.The patient was diagnosed with a venous access site complication (av fistula) that led to anemia and required a blood transfusion.Two units were anticipated but following the first infusion, the patient was suspected of having a transfusion reaction (pyrexia).The second unit was not administered.It was reported that the ae was "definitely" related to procedure.The report showed there was no possible or probable relationship to acutus medical (acm) devices.Following a site monitoring visit, an update was made to the subject file on november 13, 2020.The update stated the ae was possibly related to an acutus device.The report also stated the ae was "definitely" related to procedure.On january 7, 2020 acm received an email which provided clarification from the attending physician.The physician stated that the ae was possibly related to acqguide sheath or another non-acm sheath utilized in the procedure.The report states the ae is still "definitely" related to procedure.Patient status post event: patient was in sinus rhythm upon discharge.Issue was resolved without sequelae.
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