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

Model Number	H7493892820200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
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 moderately tortuous and severely calcified left anterior descending artery.A 2.00mm x 20mm maverick balloon catheter was advanced for dilatation.However, on the first inflation at 15 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with a different device.There were no complications, 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.
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 finding: the 2.00mm x 20mm fg maverick 2 mr was returned for analysis.A visual and tactile examination identified no issues with the hypotube shaft and outer or mid-shaft sections or the inner lumen of the device.A detailed microscopic examination of the balloon material identified a pinhole in the balloon located in the balloon material just distal to the distal markerband.There were no issues identified with the shaft polymer extrusion, markerbands, and with the bumper tip.A leakage testing was perofrmed wherein the device was attached to an encore inflation unit.A pinhole was located just distal to the distal markerband of the balloon when inflating to rated burst pressure of 14 atmospheres.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 were 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.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 failure to follow instructions.This code was selected as the most probable complaint cause based on the fact that the balloon was inflated above its rated burst pressure.The complaint reported that a balloon rupture occurred during the first inflation at 15 (atm).As per ifu for maverik 2 advise that the rate of burst pressure (rbp) is 12atm for this device.Returned device analysis confirmed the balloon material rupture with a pinhole identified in the balloon material just distal to the distal markerband.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 2.00mm x 20mm maverick? balloon catheter was advanced for dilatation.However, on the first inflation at 15 atmospheres, the balloon ruptured.The device was removed and the procedure was completed with a different device.There were no complications, and the patient condition was good 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: 24216048
• Report Number: 2124215-2026-05386
• Device Sequence Number: 18483473
• Product Code: LOX
• UDI-Device Identifier: 08714729370161
• UDI-Public: (01)08714729370161(17)280615(10)36761741
• 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): 04/07/2026

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: 0036761741
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2025
• 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: 64 YR
• Patient Sex: Male