MAUDE Adverse Event Report: ACUTUS MEDICAL, INC. ACQMAP® 3D IMAGING AND 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 12/11/2019

Event Type  Injury  

Manufacturer Narrative

It is not known what caused the pericardial effusion.It is highly unlikely that the pericardial effusion was caused by the acqmap catheter.Specifically, as stated by the acutus account manager in the event description, the acqmap catheter used in the case was not returned for investigation; the catheter was disposed of by the medical facility staff.There were several procedure related opportunities that may have contributed to or caused the event.Although a single transseptal puncture was used to access the left atrium, the procedure itself is technically demanding and carries the risk of severe complications including pericardial effusion.The acutus account manager talked to the physician after the reported adverse event and no statement by physician indicating the acqmap catheter was connected to the event.Therefore, since it cannot be determined what if any the acutus system may have played role in this event although it is likely procedure-related, and we believe reporting this event conservatively based on the available information.

Event Description

On 11 dec 2019 it was reported that standard procedural setup including standard transseptal puncture and pulmonary vein angiography were performed.The ultrasound anatomy reconstruction and atrial fibrillation baseline was recorded by the acutus acqmap system.Several attempts at direct current cardioversion (dccv) to sinus rhythm were unsuccessful.The physician then decided to ablate the anteroseptal line and posterior line.Ablation was conducted from the middle vein line to the left inferior pulmonary vein.An additional dccv attempt was unsuccessful.Extensive ablation was performed from the anterior line to the base of the left atrial appendage and the posterior line.An additional dccv attempt was unsuccessful.The ablation catheter was moved into the agilis sheath and both catheters were moved into the right atrium (ra).Coronary sinus angiography was performed and ablation in the coronary sinus was completed.An anatomy of the ra was reconstructed using the acutus acqmap system and a map was created.The acqmap catheter was retracted into the sheath and remained in the ra.At this time the physician mentioned that the patient's blood pressure was decreasing.An ultrasound echocardiogram confirmed a pericardial effusion.A pericardial puncture was initiated using standard practices wherein the pericardium was punctured via long needle below sternum.A wire was inserted to ensure no puncture of the epicardium and a pigtail catheter was used to remove blood from the paracardial sac.Patient was administered protamine to initiate blood clotting.The patient was stabilized, and the procedure was aborted.The patient left the ep lab in stable condition.

• Brand Name: ACQMAP® 3D IMAGING AND 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
• Manufacturer (Section G): ACUTUS MEDICAL, INC.; 2210 faraday avenue; suite 100; carlsbad CA 92008
• Manufacturer Contact: karen kincade ; 2210 faraday avenue; suite 100; carlsbad, CA 92008 ; 4422326123
• MDR Report Key: 9582957
• MDR Text Key: 175074412
• Report Number: 3012120746-2020-00001
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 00857042007029
• UDI-Public: (01)00857042007029(17)210731(11)190731(10)100287
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 900003
• Device Catalogue Number: 900003
• Device Lot Number: 100287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 95