MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION MAVERICK; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number	H7493892815150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	12/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced cardiopulmonary arrest (cpa) post procedure.During a pulse field ablation procedure, a versacross rf wire, a farawave nav catheter, and a 1.50mm x 15mm maverick 2 balloon catheter were selected for use.The procedure was completed.Approximately two hours after returning to the room, the patient experienced cpa.Extracorporeal membrane oxygenation (ecmo) was inserted.The patient's circulatory dynamics were stable, but brain function will be monitored for further observation.The effect of rocuronium was considered, but the anesthesiologist believed its impact was minimal.Since it was after pfa (pulmonary fibrosis ablation), and in this case, the number of pfas (67 times) was higher than usual, the cause could not be ruled out, but the exact cause was unknown.

• Brand Name: MAVERICK
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24125836
• Report Number: 2124215-2026-03747
• Device Sequence Number: 5987481
• Product Code: LOX
• UDI-Device Identifier: 08714729370055
• UDI-Public: (01)08714729370055(17)140119(10)14071010
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/20/2026

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: 01/19/2014
• Device Model Number: H7493892815150
• Device Catalogue Number: H7493892815150
• Device Lot Number: 0014071010
• 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: 12/26/2025
• Initial Report FDA Received Date: 01/20/2026
• Date Device Manufactured: 01/21/2011
• 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
• Patient Sex: Unknown