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

Model Number	H7493892815250
Medical Device Problem Codes	Nonstandard Device (1420); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
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 2.50mm x 15mm 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: fg maverick 2 mr, 2.50mmx15mm balloon was returned for analysis.A visual and tactile examination of the hypotube was broken into three parts with multiple kinks along the length.A visual inspection of the outer and inner shaft polymer extrusion and tactile examination of the entire extrusion found no issues.A microscopic examination of the balloon material identified no damages.Bumper tip showed no damage.A microscopic examination of the outer and inner shaft polymer extrusion found no issues.A leakage test identified the balloon could not be fully inflated due to a pinhole leak present at 5mm proximal of the distal markerband.The device was attached to an encore inflation unit, and the balloon was inflated.The device held pressure and inflated without issue.The encore device was verified before use by using the druck gauge, inflation was to the rate burst pressure (rbp) of 14 atmospheres (atm) as per the instructions for use.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 product investigation is assigned the most probable cause classification of adverse event related to patient condition.This code was selected as the most probable complaint cause based on the information available.It was reported that during the procedure, the balloon ruptured.It is most likely an interaction occurred between the device and the patient's challenging anatomy that contributed to the reported event.The return device analysis noted unreported hypotube break and kinks.It is most likely the device became kinked and broken due to an unintentional interaction between the user and the device, at which stage of the procedure it occurred (during procedure/handling post procedure) cannot be established.
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 2.50mm x 15mm 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: 24109010
• Report Number: 2124215-2026-03381
• Device Sequence Number: 5816509
• Product Code: LOX
• UDI-Device Identifier: 08714729370086
• UDI-Public: (01)08714729370086(17)280918(10)37492030
• 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): 03/29/2026

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: 0037492030
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 03/30/2026
• 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: 81 YR
• Patient Sex: Male