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

Model Number	900308
Medical Device Problem Codes	Unintended Movement (3026); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was discarded and is unavailable or investigation.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.Pending follow-up from the representative to clarify the reported event.A supplemental report will be submitted when information is received.
Event or Problem Description
It was reported that during a cryo ablation procedure, it was difficult to cross the septum using the integrated needle/dilator.Two attempts were made to cross the septum, and then the physician switched to using radiofrequency (rf) instead, without resolution.The sheath and the integrated needle/dilator system were removed.The 0.032 amplatz guidewire remained in and when advanced, it entered into the left atrium.After the first rf attempt the patient started to excessively cough and complained of shortness of breath.The guidewire was removed and ice imaging showed a small effusion.Protamine was administered.The patient was stable with normal vitals when leaving the operating room.The patient was admitted overnight for observation.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional informaton: b5.Corrected information: h6.
Event or Problem Description
Per follow up phone call with the rep the physician was unsure of the cause of the pericardial effusion.After attempting to cross using rf the guidewire was advanced but did not appear to cross the septum.The patient began to cough and experience shortness of breath.At this point, it was noted via ice that the guidewire seemed to be in the left atrium.The guidewire was pulled back and a small effusion was seen.Protamine was quickly administered and the procedure was stopped.There was no drop in the patient's blood pressure, and a pericardial tap was not required.The patient remained stable with normal vital signs upon leaving the procedure room and was admitted to the hospital for overnight observation without further complications.It was also noted that there were issues with ice visualization throughout the procedure, which complicated an already difficult puncture.

• Brand Name: ACQCROSS INTEGRATED NEEDLE/DILATOR
• Common Device Name: 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: 19442198
• Report Number: 3012120746-2024-00011
• Device Sequence Number: 8456112
• Product Code: DRE
• UDI-Device Identifier: 00850027837901
• UDI-Public: (01)00850027837901(11)231212(17)251210(10)105301
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K220047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2025
• Device Model Number: 900308
• Device Lot Number: 105301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Unknown