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

Model Number	900310
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Pain (1994); Pseudoaneurysm (2605); Retroperitoneal Hemorrhage (4483)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question has been discarded and is unavailable for analysis.No non-conformance were found from review of production records.Vascular perforation or damage 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.
Event or Problem Description
It was reported that during a pulsed field ablation procedure, the amplatz extra stiff guidewire kinked as the integrated dilator/needle was inserted past the level of the patient's skin.The system was removed from the patient.A new guidewire was inserted and the system re-inserted successfully.The transseptal puncture was performed successfully.The case was completed with pulsed field ablation.Three hours postoperatively, the patient complained of pain and the patient's vital signs dropped which included a vagal episode, bradycardia, and hypotension.A computerized tomography (ct) and cardiac computed tomography angiography (cta) were performed and confirmed a right external iliac venous pseudoaneurysm.The retroperitoneal bleed required intervention with blood products and extended the patient's hospitalization.The patient was reported stable throughout.No additional intervention was performed.No further patient complications have been reported as a result of this event.The physician believed the bleed occurred as a result of the first attempt to insert the flexcath cross product during the procedure.

• Brand Name: FLEXCATH CROSS INTEGRATED TRANSSEPTAL DILATOR/NEEDLE
• Common Device Name: INTEGRATED 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 ; 4422326080
• MDR Report Key: 20363182
• Report Number: 3012120746-2024-00018
• Device Sequence Number: 15423397
• Product Code: DRE
• UDI-Device Identifier: 00850027837970
• UDI-Public: (01)00850027837970(11)240327(17)260326(10)105936
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K233691
• 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): 10/03/2024

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
• Device Expiration Date: 03/26/2026
• Device Model Number: 900310
• Device Lot Number: 105936
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZ EXTRA STIFF GUIDEWIRE; MEDTRONIC FLEXCATH CONTOUR10FR SHEATH
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown