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	10/27/2025
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 a severely tortuous and severely calcified left anterior descending artery.A 1.50 mm x 15 mm maverick? balloon catheter.However, during the procedure, the balloon ruptured.The procedure was completed with a different device without any patient complications reported.The patient was in good condition.
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.: the fg maverick 2 mr 1.5mm x 15mm catheter was returned for analysis.A visual and tactile examination identified multiple kinks along the length of the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.Microscopic examination of the balloon material identified a pinhole leak at the middle markerband.Bumper tip showed no signs of distal tip damage.A leakage test was performed wherein the device was attached to an encore inflation unit, an attempt was made to inflate the device however, it failed to inflate.The device was then soaked in the water bath at 37 celsius, to allow for the matter inside to soften or breakdown.Another attempt was then made to inflate the balloon to 12 atmospheres (atm) as per, maverick 2 instructions for use (ifu), using an encore inflation aid and a pinhole was identified at the middle markerband.The device failed to inflate fully due to a pinhole in the balloon material.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a severely tortuous and severely calcified left anterior descending artery.A 1.50mm x 15mm maverick? balloon catheter.However, during the procedure, the balloon ruptured.The procedure was completed with a different device without any patient complications reported.The patient was in good condition.It was further reported that the device was advanced for dilation.

• 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: 23547543
• Report Number: 2124215-2025-82334
• Device Sequence Number: 9683343
• Product Code: LOX
• UDI-Device Identifier: 08714729370055
• UDI-Public: (01)08714729370055(17)280416(10)36317763
• 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): 01/28/2026

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: 0036317763
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2025
• 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: 73 YR
• Patient Sex: Male