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

Model Number	900200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)
Date of Event	03/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The submission of this report or related information is not necessarily an admission that our employees or our device caused or contributed to the reportable event.
Event or Problem Description
It was reported that upon inserting the acqguide max sheath to replace the baylis sheath that was inside the patient and had been used to achieve transseptal access, the patient developed st elevation on the surface ekg and hypotension with a systolic blood pressure level of approximately 50.A vizigo sheath was also inside the patient at the time of the event, and ablation on the right atrium had already been performed prior to the reported event using a biosense webster smarttouch ablation catheter.The patient was in atrial fibrillation and energy shock cardioversion was delivered to induce sinus rhythm and stabilize the low blood pressure.The hypotension and st elevation subsided after approximately 3 minutes following cardioversion delivery, and the procedure resumed without further issues.There were no patient complications or abnormal clinical symptoms reported post procedure.The physician suggested that the episode may have been related to air entering the patient during sheath insertion, and noted that the sheath had been properly flushed prior to the procedure.Air embolism is a labeled potential adverse effect associated with the use of the device.User guidance has been provided in the instructions for use to indicate that regular flushing of the sheath is recommended to prevent air emboli.The cause of the event was not established.The device functioned appropriately through the entire case without malfunctions or deficiencies alleged.The acqguide max sheath was discarded and is unavailable for investigation.It was further reported that the physician had observed st elevation immediately following acqguide max sheath insertion on a previous case.The previous event was not reported as a complaint at the time since it was not believed to be related to the acqguide sheath.There was no medical intervention required as the noted st elevation resolved on it own.The previous event has now been captured in its own complaint record as a not reportable event.

• Brand Name: ACQGUIDE MAX STEERABLE SHEATH
• Common Device Name: STEERABLE CATHETER
• Manufacturer (Section D): ACUTUS MEDICAL, INC.; 2210 faraday ave; suite 100; carlsbad CA 92008
• Manufacturer (Section G): ACUTUS MEDICAL, INC.; 2210 faraday ave; suite 100; carlsbad CA 92008
• Manufacturer Contact: claudia voss ; 2210 faraday ave; suite 100; carlsbad, CA 92008
• MDR Report Key: 16584365
• Report Number: 3012120746-2023-00002
• Device Sequence Number: 1699959
• Product Code: DRA
• UDI-Device Identifier: 00850027837017
• UDI-Public: 850027837017
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K211100
• 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): 03/21/2023

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 Model Number: 900200
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BAYLIS MEDICAL, SUREFLEX STEERABLE SHEATH.; BIOSENSE WEBSTER SMARTTOUCH ABLATION CATHETER.; BIOSENSE WEBSTER, VIZIGO GUIDING SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 100 KG