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

Model Number	H7493892820200
Medical Device Problem Codes	Nonstandard Device (1420); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.00 mm x 20 mm maverick 2 balloon catheter was advanced for dilation.However, the balloon rupture due to several calcification.The procedure was completed with a different device.There were no patient complications.Patient was in good condition.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.00mm x 20mm maverick 2 balloon catheter was advanced for dilation.However, the balloon rupture due to several calcification.The procedure was completed with a different device.There were no patient complications.Patient was in good condition.
Additional Manufacturer Narrative
Device history record review: this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Device technical analysis: fg maverick 2 mr, 2.00mm x 20mm was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.Visual and tactile inspection identified no issues with the hypotube shaft.Examination of the polymer extrusion noted a kink at 3.7cm distal to port exchange.A detailed microscopic examination of the balloon material identified a 1.5cm longitudinal balloon tear across the main body of the balloon material.Microscopic examination of the tip noted that the distal section was deformed.A microscopic examination of the proximal and distal markerbands identified no damage.Labeling review: there is no evidence that the device was used in a manner inconsistent with the labelled indications.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.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 adverse event related to patient condition as it is likely the patients challenging lesion contributed to the reported event.This code was selected as the most probable complaint cause based on the information available and the investigation conducted.Based on the event description and device, the balloon tear and unreported tip damage was most likely caused by an interaction with the stenosed, severely calcified and severely tortuous right coronary artery.Analysis identified a kink on the polymer extrusion.The unreported kink noted during device analysis occurred most likely due to post-procedure handling when repackaging the device for return.

• 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: 23532142
• Report Number: 2124215-2025-82113
• Device Sequence Number: 10026709
• Product Code: LOX
• UDI-Device Identifier: 08714729370161
• UDI-Public: (01)08714729370161(17)280610(10)36729125
• 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): 03/11/2026

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: H7493892820200
• Device Catalogue Number: H7493892820200
• Device Lot Number: 0036729125
• 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: 10/22/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 03/11/2026
• 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: Male