MAUDE Adverse Event Report: ACUTUS MEDICAL INC FLEXCATH CROSS TRANSSEPTAL SOLUTION; INTRODUCER, CATHETER

Model Number	900310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id: 10fcc13 product type: sheath product id: pscc100 product type: catheter medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that following a pulsed field ablation procedure, the patient had a small pericardial effusion at baseline prior to the procedure.The patient was found to have a pericardial effusion larger than baseline, as observed on intracardiac echocardiogram.A pulmonary vein isolation and typical flutter ablation had been completed prior to this finding.The patient was unable to maintain blood pressure due to the effusion, necessitating a pericardiocentesis, during which 240ccs of blood were removed from the pericardial space.The pericardiocentesis stabilized the patient, who was subsequently extubated and had all supporting medications discontinued before leaving the lab.The patient was monitored in the intensive care unit post-procedure, with a pericardial drain remaining in place.The case was completed with pulsed field ablation.No further patient complications have been reported as a result of this event.

• Brand Name: FLEXCATH CROSS TRANSSEPTAL SOLUTION
• Common Device Name: INTRODUCER, CATHETER
• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23005268
• Report Number: 3012120746-2025-00028
• Device Sequence Number: 13391091
• Product Code: DYB
• UDI-Device Identifier: 00850027837970
• UDI-Public: (01)00850027837970(17)261014(10)107069
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2025

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 Model Number: 900310
• Device Catalogue Number: 900310
• Device Lot Number: 107069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/09/2025
• Date Device Manufactured: 10/15/2024
• 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: SEE H11
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male