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	01/19/2026
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 severely tortuous and severely calcified left anterior descending.A 2.00mm x 20mm maverick balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported, and patient was in good condition post-procedure.
Additional Manufacturer Narrative
Investigation results: device analysis findings: an fg maverick 2 mr, 2.00mm x 20mm was returned for analysis.A visual and tactile inspection identified the balloon was subjected to positive pressure and returned in a deflated state, and a microscopic inspection identified a pinhole above the distal markerband when attempting to inflate.A visual and tactile inspection of the hypotube shaft identified no kinks or damages.A microscopic examination of the shaft polymer extrusion identified no kinks or damages.No issues or damages of the tip profile.A microscopic examination of the distal and proximal markerbands identified no damage.A leakage testing identified the device soaking in the waterbath at 37 degrees.The device was attached to an encore inflation unit and an attempt was made to inflate the balloon however a pinhole was identified above the distal markerband.The encore device was verified before and after use using the druck gauge.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.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 due to anatomical factors.This code was selected as the most probable complaint cause based on the information available.Device analysis confirmed the reported allegation as a pinhole was identified above the distal markerband.It is likely the patient lesion anatomy contributed to the reported event.The lesion was severely tortuous and severely calcified with a stenosis of 85%.
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending.A 2.00mm x 20mm maverick balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported, and 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: 24219757
• Report Number: 2124215-2026-05435
• Device Sequence Number: 15794321
• Product Code: LOX
• UDI-Device Identifier: 08714729370161
• UDI-Public: (01)08714729370161(17)280724(10)37054639
• 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): 04/17/2026

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: 0037054639
• 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: 01/30/2026
• Supplement Report FDA Received Date: 04/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2025
• 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: 82 YR
• Patient Sex: Male