MAUDE Adverse Event Report: ACUTUS MEDICAL, INC. ACQGUIDE STEERABLE SHEATH; STEERABLE CATHETER

Model Number	900002
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is not known what caused the arteriovenous fistula.As stated by the attending physician the event could possibly be related to acqguide sheath or other non-acutus medical sheaths and that the event was "definitely related" to procedure.There were several procedure-related opportunities that may have contributed to or caused the event.The procedure itself is technically demanding and carries the risk of complications including arteriovenous fistulas.Since it cannot be determined what if any role the acutus device(s) may have played in this event, acutus is conservatively reporting this event.
Event or Problem Description
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.

• Brand Name: ACQGUIDE STEERABLE SHEATH
• Common Device Name: STEERABLE CATHETER
• Manufacturer (Section D): ACUTUS MEDICAL, INC.; 2210 faraday avenue; suite 100; carlsbad CA 92008
• MDR Report Key: 11273458
• Report Number: 3012120746-2021-00002
• Device Sequence Number: 3500377
• Product Code: DRA
• UDI-Device Identifier: 00857042007012
• UDI-Public: (01)00857042007012(11)190118(10)100211(17)20200707
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K162925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2020
• Device Model Number: 900002
• Device Catalogue Number: 900002
• Device Lot Number: 100211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 82