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	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon burst.The 85% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.50mm x 15mm maverick 2 balloon catheter was advanced for dilatation.However, while trying to insert the device into the lesion, the balloon burst due to severe calcification.The procedure was completed with a different device.There were no patient 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.
Event or Problem Description
It was reported that the balloon burst.The 85% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.A 2.50mm x 15mm maverick 2 balloon catheter was advanced for dilatation.However, while trying to insert the device into the lesion, the balloon burst due to severe calcification.The procedure was completed with a different device.There were no patient 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.Device evaluated by mfr.: fg maverick 2 mr, 2.50mmx15mm, catheter was returned for analysis.Visual, tactile, microscopic analysis and functional testing was performed on the device.A visual and tactile examination of the hypotube shaft identified multiple kinks.A visual and tactile inspection of the outer and inner shaft polymer extrusion found no issues.A microscopic examination of the balloon found no issues.A microscopic examination of the shaft polymer extrusion identified no kinks or damages.A microscopic examination of the tip found no damage.A microscopic examination of the proximal and distal markerbands identified no damage.The device was attached to an encore inflation unit, and the balloon was inflated.The device held pressure and inflated to the rate burst pressure (rbp) of 14 atmospheres (atm) without issue.

• 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: 23657446
• Report Number: 2124215-2025-86824
• Device Sequence Number: 10055501
• Product Code: LOX
• UDI-Device Identifier: 08714729370086
• UDI-Public: (01)08714729370086(17)280610(10)36729116
• 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): 02/20/2026

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: 0036729116
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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: 72 YR
• Patient Sex: Male