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

Model Number 900304

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Pericardial Effusion (3271)

Event Date 02/20/2024

Event Type  Injury  

Manufacturer Narrative

Comparing prior cases with the same device, the physician postulated that given the patients atypical cardiac anatomy, the rigidity of the across with flexcath tip may have inadvertently inflicted injury to the inner layer of the right atrium.It is not clear if the pre-existing condition of the patient is related to the event.The device in question was discarded and is unavailable for investigation.No root cause could be established for this complaint.No non-conformances were noted per device history record review.Pericardial effusion is a potential clinical risk associated with the acqcross device, which is the same as the risk of a procedure performed with similar competitive devices.

Event Description

During the ablation step of a cryo ablation procedure, transseptal access was lost while attempting to maneuver from the left to the right pulmonary veins.After multiple attempts to reestablish transseptal access, a pericardial effusion developed within the right atrium.Pericardiocentesis was performed to evacuate the blood from the right side of the heart.The procedure was aborted while the patient remained under general anesthesia.The patient was hospitalized overnight, and following recovery, was discharged the next day.Prior to the procedure, it was noted that the patient had a thin septum, making transesophageal echocardiogram (tee) visualization difficult.Moreover, the guidewire was observed to advance through the septum on its own during the transseptal puncture.The physician monitored movements under tee and opted to discontinue the procedure once visualization of the cardiac anatomy was lost.It was additionally noted that the guidewire encountered kinking issues during the procedure.The issue was resolved by replacement with another manufacturer's product.

• Brand Name: ACQCROSS QX INTEGRATED NEEDLE/DILATOR
• Type of Device: INTEGRATED NEEDLE/DILATOR
• 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 ; 4422326080
• MDR Report Key: 18936622
• MDR Text Key: 338071526
• Report Number: 3012120746-2024-00003
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: 00850027837154
• UDI-Public: (01)00850027837154(11)231017(17)251015(10)105193
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• 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: 105193
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2023
• 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 STEERABLE SHEATH (4FC12)
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention