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 Code	Pericardial Effusion (3271)
Date of Event	06/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a successful pulmonary vein isolation (pvi) procedure using the pulseselect catheter, a pericardial effusion occurred during the cavo-tricuspid isthmus (cti) line ablation with another manufacturer's radiofrequency (rf) catheter.The only product present in the patient at that time the pericardial effusion was observed was the contour sheath.The pericardial effusion was detected, and a pericardiocentesis was performed as treatment.The event led to an extended hospitalization for the patient.The case was completed with pulsed field ablation.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id: psg100 (serial: (b)(6); product type: 3294-generator product id pscc100 (0012715330); product type: 0609-catheter.Product id: 10fcc13 (unknown serial/lot); product type: 0629-flexcath sheath.Product id: non-medtronic, 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.

• 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: 22307353
• Report Number: 3012120746-2025-00021
• Device Sequence Number: 18163105
• Product Code: DYB
• UDI-Device Identifier: 00850027837970
• UDI-Public: 00850027837970
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/23/2025

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 Expiration Date: 08/08/2026
• Device Model Number: 900310
• Device Catalogue Number: 900310
• Device Lot Number: 106647
• 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: 06/04/2025
• Initial Report FDA Received Date: 06/23/2025
• Date Device Manufactured: 08/09/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 91 KG