MAUDE Adverse Event Report: ACUTUS MEDICAL, INC. ACQGUIDE MAX STEERABLE SHEATH; STEERABLE CATHETER

Model Number 900200

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Tamponade (2226)

Event Date 06/30/2023

Event Type  Injury  

Event Description

Field service engineer reported that that a transseptal puncture was performed with acqguide max in combination with acqcross max under tee guidance.Once positioned in the la, a quadripolar catheter was advanced through the acqguide.A second transseptal (abbott, agilis) was also performed under tee guidance.Insertion of lasso was advanced through the agilis.All four pulmonary veins were mapped, and three veins were reconnected.The acqmap catheter preparation reportedly went well with no abnormalities observed (normal basket shape outside the patient); however, after insertion into the la, it was observed that the basket shape could not be opened completely.Acqmap was removed and was re-tested outside the patient.Again, no abnormalities observed.At that moment, 30 minutes after the first transseptal puncture, a blood pressure drop was observed.A transthoracic echo confirmed the presence of fluid/blood in the epicardial space.An immediate intervention was required.An epicardial puncture was used to aspirate the blood from the pericardial space.Following, the cardiac surgeon performed a sternotomy and detected a perforation of the left atrial appendage.The perforation was closed, followed by closure of the sternum.Patient was transferred to the icu for further observation and per follow-up with director, sales and business development, patient status/condition was not able to be obtained as physician did not provide these details due to patient and center privacy reasons.

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.Per follow-up, it was reported that the physician believes two related events could have caused the perforation: 1) due to the unsuccessful insertion of the lasso catheter inside the acqguide, they created some unnecessary movements with the acqguide leading to the perforation and 2) the distal position of the acqguide the time the quadripolar was advanced / inserted.However, product was analyzed and found to meet specifications.No external damage or defects were noted.Insufficient information is available to establish a causal relationship between the device and the reported adverse event.Conclusion and root cause cannot be established.A supplemental mdr will be submitted if additional information is reported.

• Brand Name: ACQGUIDE MAX STEERABLE SHEATH
• Type of Device: STEERABLE CATHETER
• Manufacturer (Section D): ACUTUS MEDICAL, INC.; 2210 faraday ave; suite 100; carlsbad CA 92008
• Manufacturer (Section G): ACUTUS MEDICAL, INC.; 2210 faraday ave; suite 100; carlsbad CA 92008
• Manufacturer Contact: james bennett ; 2210 faraday ave; suite 100; carlsbad, CA 92008 ; 4422326103
• MDR Report Key: 17354683
• MDR Text Key: 319337880
• Report Number: 3012120746-2023-00005
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K211100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 900200
• Device Catalogue Number: 900200
• Device Lot Number: LN104096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ACUTUS ACQMAP 3D IMAGING AND MAPPING CATHETER; AGILIS NXT STEERABLE INTRODUCER; BIOSENSE WEBSTER LASSO CATHETER
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 92 KG