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

Model Number	900304
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Pericarditis (4448)
Date of Event	01/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following a cryo ablation procedure, the patient experienced several adverse events.The patient presented to the emergency department with chest pain and shortness of breath.The chest pain was located in the middle of the chest.Post-ablation pericarditis was identified.Diagnostic tests included a blood test showing mild leukocytosis and mild thrombocytopenia, an electrocardiogram indicating normal sinus rhythm, an echocardiogram with an ejection fraction of 64% and no pericardial effusion, and an x-ray showing no acute process.Interventions included administration of opioid, a non-steroidal anti-inflammatory drug, and a mineral supplement.The patient was hospitalized for observation and subsequently recovered.The outcome of this case is unknown.No further patient complications have been reported as a result of this event.2025-05-09: it was later reported that the case was completed with cryo.
Additional Manufacturer Narrative
Continuation of d10: product id: 900304, product type: integrated dilator needle; product id: afapro28, product type: balloon catheter; product id: 4fc12, product type: sheath; product id: medtronic unknown, product type: mapping 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: 22022349
• Report Number: 2182208-2025-02354
• Device Sequence Number: 18512642
• Product Code: DYB
• UDI-Device Identifier: 00850027837826
• UDI-Public: 00850027837826
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/14/2025

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: 02/13/2026
• Device Model Number: 900304
• Device Catalogue Number: 900304
• Device Lot Number: 105723
• 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: 04/18/2025
• Initial Report FDA Received Date: 05/14/2025
• Date Device Manufactured: 02/15/2024
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 86 KG