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	12/03/2025
Type of Reportable Event	Malfunction
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 artery.A 2.00mm x 15mm maverick? balloon catheter was advanced for dilation.However, during inflation, the ballon burst.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.
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.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.Device technical analysis: the 2.00mm x 15mm fg maverick 2 mr catheter was returned for analysis.Visual and tactile inspection revealed kinks along the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.A microscopic examination of the balloon identified no issues or damages.The distal tip showed no signs of damage.A microscopic examination of the proximal and distal markerbands identified no damage.Leakage testing was performed wherein the device was attached to an encore inflation device.The balloon inflated to rated burst pressure without an issue and the balloon deflated without any issues.No other device issues or defects were identified during returned product analysis.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 no problem detected, based on the device analysis.This conclusion code is based on the available information and the review or testing conducted at the complaint investigation site.The complaint reported that during inflation, the balloon burst due to severe calcification.The device was attached to an encore inflation device during analysis testing, and the balloon was inflated to rated burst pressure without an issue.The balloon deflated without any issues.The reported allegation cannot be confirmed based on the device analysis results.The unreported hypotube kinks are indicative of excessive force being applied to the delivery system however, at which stage of the procedure it occurred (during procedure or handling post procedure) cannot be established.
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 artery.A 2.00mm x 15mm maverick? balloon catheter was advanced for dilation.However, during inflation, the ballon burst.The procedure was completed with a different device.No patient complications were reported, 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: 23853449
• Report Number: 2124215-2025-92094
• Device Sequence Number: 9571781
• Product Code: LOX
• UDI-Device Identifier: 08714729370062
• UDI-Public: (01)08714729370062(17)280807(10)37159521
• 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): 03/16/2026

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: 0037159521
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2025
• 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: 63 YR
• Patient Sex: Male