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

Model Number	H7493892815250
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
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.Following pre-dilatation, a 2.50mm x 15mm maverick balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst due to severe calcification.The device was removed successfully from the patient's body, and the procedure was completed with another of same device.There were no patient complications reported, and the patient was in good condition post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg maverick 2 mr, 2.50mm x 15mm, catheter was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination identified multiple hypotube kinks along the length of the hypotube shaft.A visual and tactile examination of the shaft polymer extrusion identified no issues with the outer / mid-shaft sections or the inner lumen of the device.A detailed microscopic examination of the balloon material identified a balloon tear located approximately 3 mm proximal to the distal markerband.A microscopic examination of the proximal and distal markerbands identified no damage.Tip showed no signs of tip damage.
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.Following pre-dilatation, a 2.50mm x 15mm maverick balloon catheter was advanced for dilatation.However, during the procedure, the balloon burst due to severe calcification.The device was removed successfully from the patient's body, and the procedure was completed with another of same device.There were no patient complications reported, 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: 22555180
• Report Number: 2124215-2025-48729
• Device Sequence Number: 9559477
• 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): 10/29/2025

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: 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: 07/09/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 10/29/2025
• 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: 77 YR
• Patient Sex: Female