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

Model Number	H7493892815150
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Chest Pain (1776); Vascular Dissection (3160)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a balloon rupture occurred resulting in coronary dissection.The patient underwent a coronary intervention procedure during which a calcified coronary lesion with sharp nodular structure was identified.Pre-dilation was performed using a 1.50 mm x 15 mm maverick 2 balloon catheter.During the third balloon inflation at 12 atmospheres for 30 seconds, the balloon ruptured, resulting in a non-flow-limiting type c coronary artery dissection.The patient experienced chest pain, and immediate pain relief was provided.To manage the dissection and restore coronary blood flow, a new 1.50 mm x 15 mm balloon catheter was introduced and used for further dilation of the lesion.Following this intervention, coronary blood flow was restored, and no additional complications were noted at the time of reporting.

• 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22311851
• Report Number: 2124215-2025-39376
• Device Sequence Number: 18389534
• Product Code: LOX
• UDI-Device Identifier: 08714729370055
• UDI-Public: (01)08714729370055(17)271107(10)35232304
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493892815150
• Device Catalogue Number: H7493892815150
• Device Lot Number: 0035232304
• 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: 05/29/2025
• Initial Report FDA Received Date: 06/23/2025
• Date Device Manufactured: 11/07/2024
• 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
• Patient Age: 67 YR
• Patient Sex: Female