MAUDE Adverse Event Report: ACUTUS MEDICAL, INC. ACQCROSS QX INTEGRATED TRANSSEPTAL DILATOR/NEEDLE

Model Number 900304

Device Problem Difficult to Advance (2920)

Patient Problems Pericardial Effusion (3271); Thrombosis/Thrombus (4440)

Event Date 04/24/2023

Event Type  Injury  

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.The disposition of the device in question is unknown and is therefore unavailable for investigation.No root cause could be established for this event.Supplemental mdr will be submitted if/when additional information is received.

Event Description

The acqcross system was employed for a transseptal puncture procedure guided by fluoroscopy and transesophageal echo (tee).However, during the initial setup, there were difficulties in fitting the acqcross onto the flexcath, despite following the recommended up and down movements.At this point, the option of exchanging the system for another of the same model was presented to the doctor, but it was deemed unnecessary.It was noted that the patient was not under general anesthesia.The doctor attempted to introduce guidewire into the patient through the left femoral vein, but the guidewire became entangled in a venous kink, preventing it from advancing.Using fluoroscopy as a guide, the guidewire was removed, and a new one was inserted.With the new wire in place, the acqcross-flexcath (acq-fc) system was successfully advanced to the superior vena cava (svc).From there, they descended into the right atrium (ra) with the intention of reaching the fossa ovalis, all the while guided by both fluoroscopy and tee.Upon reaching the fossa ovalis, the doctor made the decision to return to the svc to reposition the system before proceeding with the puncture.During this second pass into the ra, a pericardial effusion was detected on the tee, necessitating pericardiocentesis.Additionally, clots were detected in the pericardium and a small incision was made to access the pericardium and to aspirate the clots.The patient left the hemodynamics room in stable condition.Per follow-up, the pericardiocentesis did not resolve the pericardial effusion.Clots were detected in the pericardium due to patient stopping the anticoagulant therapy.A small incision was made in the thorax in order to access the pericardium and aspirate them.The patient was hospitalized during recovery and was discharged two days after the procedure without complications.No further patient complications have been reported as a result of this event.

• Brand Name: ACQCROSS QX INTEGRATED TRANSSEPTAL DILATOR/NEEDLE
• Type of Device: TRANSSEPTAL DILATOR/NEEDLE
• 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: 17846496
• MDR Text Key: 324625346
• Report Number: 3012120746-2023-00008
• Device Sequence Number: 1
• Product Code: DRE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K210685
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 900304
• Device Lot Number: 103787
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• 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
• Treatment: FLEXCATH ADVANCE STEERABLE SHEATH (4FC12)
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening