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

Model Number	H7493892815150
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
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 90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 1.50mm x 15mm maverick? balloon catheter was advanced for dilation.However, during inflation, the balloon 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.Investigation results: device analysis findings: a partial of 1.50mm x 15mm fg maverick 2 mr balloon catheter was returned for analysis.A visual and tactile inspection identified no issues with the hypotube shaft.A visual inspection of the balloon noted a complete circumferential balloon tear 22.3cm distal to the port exchange.The distal section from the location of the tear did not return for analysis.A visual inspection of the shaft polymer extrusion noted that there was a tear in the inner lumen at the same location as the circumferential balloon tear with the distal section of the break not returned for analysis.A microscopic examination noted that both markerbands were not returned for analysis.It was not possible to perform a leakage test on the device for the reported rupture due to the distal section of the break/tear not returning.No other device issues/defects were identified during returned product analysis.Device history record review: it was confirmed that this device met manufacturing specification prior to distribution and there are 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 (prr) table.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 adverse event related to patient condition as it was reported that during inflation, the balloon burst due to severe calcification.This conclusion code is based on the available information and the review conducted at the complaint investigation site.It was observed during device analysis that the distal section of the device, from the location of the balloon tear and the unreported break in the inner lumen (the same location), did not return for analysis therefore it was not possible to perform a leakage test on the device, however device analysis confirmed the reported balloon burst as the balloon tear was an complete circumferential tear that was observed.
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 1.50mm x 15mm maverick balloon catheter was advanced for dilation.However, during inflation, the balloon 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: 23853517
• Report Number: 2124215-2025-92103
• Device Sequence Number: 18541546
• Product Code: LOX
• UDI-Device Identifier: 08714729370055
• UDI-Public: (01)08714729370055(17)280624(10)36833982
• 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): 03/27/2026

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: H7493892815150
• Device Catalogue Number: H7493892815150
• Device Lot Number: 0036833982
• 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: 03/10/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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: 70 YR
• Patient Sex: Male