MAUDE Adverse Event Report: ACUTUS MEDICAL, INC. ACQCROSS QX INTEGRATED TRANSSEPTAL DILATOR/NEEDLE; TRANSSEPTAL DILATOR/NEEDLE,

Model Number	900304
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	05/15/2023
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 as the physician removed the wire and dilator, and was getting the side port flush connected, the patient desaturated into the low 90s/high 80s and became hypotensive in the 90s/60s.Reportedly, the flexcath and acqcross were advanced to the atrial septum.The physician tented the septum, extended the acqcross needle, advanced the wire into the lspv (left superior pulmonary vein), and retraced the needle.Then the physician advanced the flexcath and acqcross transeptal into the left atrium, removed the wire and dilator, and hooked up the flexcath side port to a heparin flush line.At the same time, the patient's oxygen saturations decreased, and the patient became hypotensive.The physician looked on fluoroscopy for pericardial effusion and did not see any air moving in the patient's thorax and looked again on intracardiac echocardiography(ice) and did not see any effusion.The anesthetist then gave a vasopressor to address the patient becoming hypotensive and the physician decided to move forward with the procedure and began prepping the cryoballon.Then the patient began having st segment elevation that lasted approximately a minute.The physician then checked again for an air embolism.The patient's saturations rose back to 100% and the blood pressure became hypertensive in the 170s systolic and the st segment elevation went away.The case was completed successfully with no other incident.The physician believes the issue was due to a vagal response.Although, it is not clear what caused all of this it was hypothesized that the manipulation of the intra septal and left atrial ganglion plexuses by the transseptal needle and sheath caused an imbalance in autonomic innervation, which lead to a coronary artery spasm and st-segment elevation.There was no allegation of malfunction or deficiency related to the acutus device.The device in question was discarded by the hospital and is not expected to be returned for investigation.

• Brand Name: ACQCROSS QX INTEGRATED TRANSSEPTAL DILATOR/NEEDLE
• Common Device Name: TRANSSEPTAL DILATOR/NEEDLE,
• Manufacturer (Section D): ACUTUS MEDICAL, INC.; 2210 faraday avenue; suite100; carlsbad CA 92008
• Manufacturer (Section G): ACUTUS MEDICAL, INC.; 2210 faraday ave; suite 100; carlsbad CA 92008
• Manufacturer Contact: claudia voss ; 2210 faraday ave; carlsbad, CA 92008 ; 4422326081
• MDR Report Key: 17081408
• Report Number: 3012120746-2023-00004
• Device Sequence Number: 2250433
• Product Code: DRE
• UDI-Device Identifier: 00850027837147
• UDI-Public: (01)00850027837147
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K210685
• 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): 06/07/2023

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: 900304
• Device Catalogue Number: 900304
• 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: 05/23/2023
• Initial Report FDA Received Date: 06/07/2023
• 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: FLEXCATH SHEATH; MEDTRONIC ARCTIC FRONT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 101 KG