MAUDE Adverse Event Report: ACUTUS MEDICAL, INC. FLEXCATH CROSS TRANSSEPTAL SOLUTION; TRANSSEPTAL INTERATED DILATOR/NEEDLE

Model Number	900308
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vascular perforation is a is a potential clinical risk associated with the flexcath cross device, which is the same as the risk of a procedure performed with similar, competitive devices.No non-conformances were found after an analysis of production records.
Event or Problem Description
It was reported that during a procedure to place a left atrial appendage (laa) closure device from another manufacturer, the dilator/transseptal needle and sheath were advanced into the external iliac vein.It was further reported that patient's blood pressure dropped, and an external iliac vein perforation occurred.A balloon angioplasty was performed to stop the bleeding.The patient was under general anesthesia.The case was aborted.A computerized tomography (ct) was performed and confirmed that the bleeding had stopped.No further patient complications have been reported as a result of this event.Per follow up from the representative there were no complications or observations noted prior to the event.No device malfunction or issue was reported.

• Brand Name: FLEXCATH CROSS TRANSSEPTAL SOLUTION
• Common Device Name: TRANSSEPTAL INTERATED 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
• MDR Report Key: 20510372
• Report Number: 3012120746-2024-00019
• Device Sequence Number: 17942881
• Product Code: DRE
• UDI-Device Identifier: 00850027837901
• UDI-Public: (01)00850027837901(11)240119(17)260117(11)105559
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 10/22/2024

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: 01/17/2026
• Device Model Number: 900308
• Device Lot Number: 105559
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2024
• 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
• Patient Sex: Unknown