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U.S. Department of Health and Human Services

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

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ACUTUS MEDICAL, INC. ACQMAP 3D IMAGING & MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY Back to Search Results
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.
 
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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 Key10525056
MDR Text Key206738629
Report Number3012120746-2020-00004
Device Sequence Number1
Product Code MTD
UDI-Device Identifier00857042007029
UDI-Public(01)00857042007029(17)220204(10)100383(11)200204
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K170819
Number of Events Reported1
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 Date02/04/2022
Device Model Number900003
Device Catalogue Number900003
Device Lot Number100383
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/20/2020
Initial Date FDA Received09/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age51 YR
Patient Weight104
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