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

Model Number	900304
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	04/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was discarded and a failure investigation could not be performed.There were no non-conformances found per the device history review.Pericardial effusion is an inherent clinical risk associated with the acqcross integrated needle/dilator device, which is the same as the risk of a procedure performed with similar, competitive devices.
Event or Problem Description
It was reported that the physician advanced the flexcath cross system into the superior vena cava svc, but had trouble positioning on septum due to atrial pacing lead.The physician obtained transseptal access with versacross wire, but was unable to get flexcath sheath across the septum.A drop in patient's blood pressure was noted.The physician then utilized intracardiac echocardiography ice to visualize an effusion around the patient's heart.A pericardiocentesis was performed and 350cc of blood was removed.The case was aborted.The patient was stabilized and admitted to the icu.

• 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: 19347047
• Report Number: 3012120746-2024-00008
• Device Sequence Number: 16796237
• Product Code: DRE
• UDI-Device Identifier: 00850027837826
• UDI-Public: (01)00850027837826(11)231107(17)251105(10)105298
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K210685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/17/2024

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: 11/05/2025
• Device Model Number: 900304
• Device Lot Number: 105298
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLEXCATH SHEATH.; VERSACROSS RF WIRE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Unknown