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

Model Number	H7493892815250
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous coronary intervention.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.50mm x 15mm maverick 2 balloon catheter was advanced for dilatation.However, while trying to insert the device into the lesion, the balloon burst due to severe calcification.The device was removed successfully, and the procedure was completed with another of the same device.There were no patient complications, and the patient was in good condition post-procedure.
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.
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.Device history record review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Device technical analysis: maverick 2 mr, 2.50mm x 15mm from catheter was returned for analysis.Visual, tactile, microscopic analysis and leakage testing was performed on the device.A visual and tactile inspection of the hypotube shaft identified no issues.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.The device was attached to an encore inflation device.The encore device was verified before use by using the druck gauge.An attempt was then made to inflate the balloon to 14 atmospheres as per, maverick 2, instructions for use, however, it was observed that a leak was occurring.Microscopic examination of the balloon material identified an 8mm longitudinal tear in the midsection of the balloon.Bumper tip showed no signs of distal tip damage.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review table.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a most probable investigation conclusion code of adverse event related to patient condition.This conclusion code is based on the available information, reported anatomical characteristics and the returned product analysis performed at boston scientific site.Based on the available information the observed damage was likely due to interaction between this device and the challenging anatomical conditions present in the vessel being treated (90% stenosis, severe calcification and severe tortuosity).
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous coronary intervention.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.50mm x 15mm maverick 2 balloon catheter was advanced for dilatation.However, while trying to insert the device into the lesion, the balloon burst due to severe calcification.The device was removed successfully, and the procedure was completed with another of the same device.There were no patient complications, and the patient was in good condition post-procedure.

• 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: 23739425
• Report Number: 2124215-2025-89477
• Device Sequence Number: 10350356
• Product Code: LOX
• UDI-Device Identifier: 08714729370086
• UDI-Public: (01)08714729370086(17)280610(10)36729116
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: H7493892815250
• Device Catalogue Number: H7493892815250
• Device Lot Number: 0036729116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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: 72 YR
• Patient Sex: Female