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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that balloon rupture occurred.On (b)(6) 2025, a patient underwent coronary angiography and stent implantation.At approximately 10:40 am, balloon dilation was being performed using a percutaneous transluminal coronary angioplasty (ptca).A 1.50mm x 15mm maverick? balloon catheter was advanced for dilation.However, it was noticed that the balloon ruptured.The device was completely removed.Subsequently, another device was use and the procedure was resumed around 11:00 am.The remainder of the procedure was carried out without incident.The rupture of the balloon during the procedure resulted in an extension of the procedure time by nearly 20 minutes.No patient complications were reported.
Additional Manufacturer Narrative
B5 - updated describe event or problem.
Event or Problem Description
It was reported that balloon rupture occurred.On (b)(6) 2025, a patient underwent coronary angiography and stent implantation.At approximately 10:40 am, balloon dilation was being performed using a percutaneous transluminal coronary angioplasty (ptca).A 1.50mm x 15mm maverick? balloon catheter was advanced for dilation.However, it was noticed that the balloon ruptured.The device was completely removed.Subsequently, another device was use and the procedure was resumed around 11:00 am.The remainder of the procedure was carried out without incident.The rupture of the balloon during the procedure resulted in an extension of the procedure time by nearly 20 minutes.No patient complications were reported.It was further reported that the 80% stenosed target lesion was located in a mildly tortuous and mildly calcified left anterior descending artery.The balloon ruptured during the first inflation.The device was pulled out directly.

• 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: 23498013
• Report Number: 2124215-2025-80843
• Device Sequence Number: 15668080
• Product Code: LOX
• UDI-Device Identifier: 08714729370055
• UDI-Public: (01)08714729370055(17)280407(10)36248751
• 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,Followup
• Report Date (Section B): 11/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493892815150
• Device Catalogue Number: H7493892815150
• Device Lot Number: 0036248751
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 11/28/2025
• Date Device Manufactured: 04/08/2025
• 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
• Patient Age: 71 YR
• Patient Sex: Female