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 08/20/2020

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 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.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.The physician could not specifically say that the acqmap catheter caused the event.However, since it cannot be determined what if any role the acutus devices may have played in this event, acutus is reporting this event to be conservative.

Event Description

Patient history: a male patient (age (b)(6); weight (b)(6) kg) was treated on (b)(6) 2020.The de-novo ablation was used to treat the patient's paroxsysmal atrial fibrillation.The patient had been prescribed flecanide for the paroxysmal atrial fibrillation.Description of the event: it was reported that the bi-atrial procedural steps based on standard of care were utilized to access the patient's right and left atriums.Note: the bi-atrial use of two acqmap catheters is only approved in europe.The bi-atrial procedure typically requires two transseptal punctures.However, during this case only one transseptal puncture was required.It was suspected that the second guidewire was placed in a foramen ovale, however a transoesophageal echocardiogram and transthoracic echocardiogram could not confirm the guidewire placement.The acqmap catheter and the acqguide steerable sheath were positioned in the right atrium where a map was created, and ablations were performed with the abbott¿ tacticath¿ sensor enabled catheter without incident.The acqmap catheter was then positioned in the right atrium/superior vena cava junction while a second acqmap catheter was placed into position in the left atrium.The left atrium was mapped using the acqmap catheter and ablations were performed with the abbott¿ tacticath¿ sensor enabled catheter without incident.After an unknown period-of-time, the physician pulled back on the right atrial guidewire to move the guidewire and acqmap catheter back into position to create another right atrial map.During the last hour of treatment, the patient's blood pressure was low and became increasingly difficult for the anesthesiologist to manage.The low blood pressure did not trigger an alert from the anesthesiologist and the case continued.Upon completing the case, a transthoracic echocardiogram confirmed the presence of a pericardial effusion.A subxiphoid pericardiocentesis was performed and approximately 650ml was removed from the pericardial space.The pericardiocentesis did not stabilize the patient.During the pericardiocentesis, the physician noted a blood clot that caused partial collapse of the patient's right ventricle.Several attempts were made to remove the clot during pericardiocentesis.However, the clot could not be extracted via the subxiphoid catheter due to the clot's size and consistency.Protamine was then administered to reverse the effects of heparin anticoagulant.Surgical intervention was not necessary to resolve the pericardial effusion or the blood clot.The origin of the pericardial effusion could not be determined.Patient status post event the physician informed acutus that the patient was "doing well" 24 hours post procedure.No subsequent sequelae have been reported to acutus.

• 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
• 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: 10525056
• MDR Text Key: 206738629
• Report Number: 3012120746-2020-00004
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 00857042007029
• UDI-Public: (01)00857042007029(17)220204(10)100383(11)200204
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 09/11/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2022
• Device Model Number: 900003
• Device Catalogue Number: 900003
• Device Lot Number: 100383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2020
• 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: 51 YR
• Patient Weight: 104