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	Pulmonary Embolism (1498); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)
Date of Event	08/05/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that during a cardiac ablation procedure the patient passed away.It was noted that the patient experienced a sudden drop in blood pressure and a sudden decrease in oxygen saturation, while ablating in the right superior pulmonary vein.The patient subsequently experienced a cardiac arrest, necessitating cardiopulmonary resuscitation measures.Intracardiac echocardiogram showed a similar baseline effusion prior to ablation, and an echocardiogram performed by the anesthesia, revealed a large right ventricular clot.Activated clotting time was measured multiple times, with results of 190, 211, and 186.The patient received 15,000 units of heparin, followed by additional doses of anticoagulant, multiple rounds of epinephrine, bicarbonate, and anticholinergic medications.An impella device was inserted into the left ventricle.Despite resuscitation efforts for one hour, the patient could not be revived and expired on the table.The physician attributed the event to a large pulmonary embolism.
Additional Manufacturer Narrative
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: 22931984
• Report Number: 3012120746-2025-00027
• Device Sequence Number: 10294601
• Product Code: DYB
• UDI-Device Identifier: 00850027837970
• UDI-Public: (01)00850027837970(17)260811(10)106645
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 09/01/2025

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: 08/11/2026
• Device Model Number: 900310
• Device Catalogue Number: 900310
• Device Lot Number: 106645
• 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: 08/05/2025
• Initial Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 08/12/2024
• 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: Death
• Patient Age: 62 YR
• Patient Sex: Male