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	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous coronary intervention.The 90% 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 was in good condition post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg maverick 2 mr 2.50mm x 15mm balloon catheter was returned for analysis.Visual, tactile, microscopic and a leakage test was performed on the device.A visual and tactile examination of the hypotube noted multiple hypotube kinks along its length.A visual and tactile examination of the shaft polymer extrusion showed no kinks or damages.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.A microscopic examination of the tip showed no signs of tip damage.Using an encore inflation unit, the balloon was inflated to its rated burst pressure (rbp) of 14 atmospheres (atm) as per instructions for use.The balloon inflated fully and maintained pressure for 15 seconds, with no leaks noted.A vacuum was applied, and the balloon deflated fully with no resistance.The balloon was inflated to its rbp on three more occasions with no leaks noted.
Event or Problem Description
It was reported that balloon rupture occurred.The patient underwent percutaneous coronary intervention.The 90% 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 was in good condition 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: 23310109
• Report Number: 2124215-2025-72370
• Device Sequence Number: 20280804
• Product Code: LOX
• UDI-Device Identifier: 08714729370086
• UDI-Public: (01)08714729370086(17)280421(10)36342828
• 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): 01/04/2026

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: 0036342828
• 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: 09/24/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 01/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2025
• 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