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

Model Number	H7493892815200
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.During a percutaneous coronary intervention (pci), the patient presented with a 50% stenosed target lesion in the mildly tortuous and mildly calcified left anterior descending (lad) artery.The lesion had an angulation of less than 45 degrees.A 2.00 mm x 15 mm maverick? balloon catheter was advanced for pre-dilation.However, during procedure, the push rod of the balloon catheter broke.The procedure was successfully completed with another of the same device.No patient complications were reported, and the patient remained stable 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.E1 initial reporter phone: (b)(6).
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.E1 initial reporter phone: (b)(6).H6 device codes: updated.
Event or Problem Description
It was reported that shaft break occurred.During a percutaneous coronary intervention (pci), the patient presented with a 50% stenosed target lesion in the mildly tortuous and mildly calcified left anterior descending (lad) artery.The lesion had an angulation of less than 45 degrees.A 2.00 mm x 15 mm maverick? balloon catheter was advanced for pre-dilation.However, during procedure, the push rod of the balloon catheter broke.The procedure was successfully completed with another of the same device.No patient complications were reported, and the patient remained stable post-procedure.It was further reported that the shaft broke while attempting to cross the lesion.

• 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: 23535316
• Report Number: 2124215-2025-81427
• Device Sequence Number: 10167676
• Product Code: LOX
• UDI-Device Identifier: 08714729370062
• UDI-Public: (01)08714729370062(17)280220(10)35897971
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

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: 0035897971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 11/30/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/19/2025
• Date Device Manufactured: 02/20/2025
• 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: 49 YR
• Patient Sex: Male