MAUDE Adverse Event Report: ACUTUS MEDICAL, INC. ACQMAP 3D IMAGING & MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number 900003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pericardial Effusion (3271)

Event Date 12/22/2020

Event Type  Injury  

Manufacturer Narrative

It is unknown what caused the pericardial effusion.It is highly unlikely that the event was caused by the acm devices.As stated in the event description by the acutus account manager, the acqmap catheter and acqguide max sheath functioned without any reported incident that would have led to the pericardial effusion.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 severe complications including pericardial effusion.Since it cannot be determined what if any role the acutus devices may have played in this event, acutus is conservatively reporting this event.

Event Description

Patient history: a male patient ((b)(6)) was treated on (b)(6) 2020.The redo ablation was used to treat the patient's infrequent premature atrial contractions and atrial fibrillation.It is unknown if the patient was on any medication prior to the procedure.Description of the event: an acutus representative attended the procedure.It was reported that the acutus medical inc.(acm) acqmap catheter and acqguide max sheath were used during the procedure and that no difficulties were experienced in deploying, collapsing, and/or withdrawing the acm devices for each of the 6 maps created.The abbott¿ ensite precision¿ cardiac mapping system (precision) and the advisor¿ hd grid mapping catheter, sensor enabled¿ (hd grid), also were used during the case.The precision and hd grid were initiated to create an anatomy of the left atrium.All veins had been isolated.The patient was induced into atrial fibrillation with the st.Jude medical¿ inquiry¿ electrophysiology catheter, decapolar.The acqmap catheter was used to create 6 maps in the left atrium and selected sites were ablated with the abbott¿ tacticath¿ sensor enabled catheter.Towards the end of the procedure and after all the devices were removed the patient's blood pressure dropped.Routine ultrasound scan confirmed a pericardial effusion.Pericardiocentesis was performed and 600ml of blood/fluid were removed from the pericardial space.Protamine was then administered to reverse the effects of heparin anticoagulant.Surgical intervention was not necessary to resolve the pericardial effusion.Patient status post event: the physician informed acutus that the patient was doing well.Patient has been discharged and no subsequent sequelae have been reported to acutus.

Manufacturer Narrative

D4: added lot number.D4: added expiration date.D4: added udi number.H4: added device manufacturer date.

• Brand Name: ACQMAP 3D IMAGING & MAPPING CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): ACUTUS MEDICAL, INC.; 2210 faraday avenue; suite 100; carlsbad CA 92008
• MDR Report Key: 11197439
• MDR Text Key: 227731543
• Report Number: 3012120746-2021-00001
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• PMA/PMN Number: K170819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2022
• Device Model Number: 900003
• Device Lot Number: 100535
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT¿ ENSITE PRECISION¿ CARDIAC MAPPING SYSTEM; ABBOTT¿ TACTICATH¿ SENSOR ENABLED CATHETER; ACQGUIDE MAX SHEATH; ADVISOR¿ HD GRID MAPPING CATHETER, SENSOR ENABLED¿; ST. JUDE MEDICAL¿ INQUIRY¿
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 90