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

Model Number	H7493892815200
Medical Device Problem Codes	Nonstandard Device (1420); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
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.The 85% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm x 15mm maverick balloon catheter was advanced for dilation.However, during inflation, the balloon burst.The device was removed, and the procedure was completed with a different device.No patient complications were reported, and the patient condition was good post-procedure.
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm x 15mm maverick? balloon catheter was advanced for dilation.However, during inflation, the balloon burst.The device was removed, and the procedure was completed with a different device.No patient complications were reported, and the patient condition was good 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.Investigation results: device analysis findings: the 2.00mm x 15mm fg maverick 2 mr dilation catheter was returned for analysis.A visual and tactile examination shows the balloon was subjected to positive pressure and was returned in a deflated state.Multiple kinks were identified along the hypotube shaft.A detailed microscopic examination of the balloon material identified no issues.No issues were noted with the bumper tip.A microscopic examination of the distal and proximal markerbands identified no damage.No kinks or damages on the shaft polymer extrusion.A leakage testing was performed wherein the device was left soaking in the waterbath at 37 degrees.The device was then attached to an encore inflation device.The balloon was inflated to rated burst pressure of 12 atmospheres with no issues.No other device issues were identified during returned product analysis.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.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 conclusion code of no problem detected.This code was selected as the most probable complaint cause based on the device analysis.It was reported that balloon rupture occurred due to severe calcification.Leakage testing inflated the balloon to 12 atmospheres without any issues.The balloon could be inflated and deflated with no issues.

• 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: 24307998
• Report Number: 2124215-2026-07514
• Device Sequence Number: 5142415
• Product Code: LOX
• UDI-Device Identifier: 08714729370062
• UDI-Public: (01)08714729370062(17)280918(10)37490217
• 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): 04/03/2026

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: H7493892815200
• Device Catalogue Number: H7493892815200
• Device Lot Number: 0037490217
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2025
• 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: 65 YR
• Patient Sex: Male