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

Model Number	H7493892815150
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	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.
Event or Problem Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery (lad).A 1.50mm x 15mm maverick 2 balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported, and the patient was in good condition post procedure.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.The device was returned for analysis.Visual and tactile inspection indicated that the balloon had been subjected to positive pressure and was returned in a deflated state.A 5 mm longitudinal tear was observed in the proximal section of the balloon, approximately 14 mm from the distal tip.Multiple kinks were noted along the hypotube shaft.Microscopic analysis confirmed the 5 mm longitudinal tear in the same location and revealed stretching of the inner lumen within the balloon material.No issues or damage were identified at the tip.Microscopic examination of the markerband also showed no damage.No additional device issues were found during the returned product analysis.
Event or Problem Description
It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery (lad).A 1.50mm x 15mm maverick 2 balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured.The procedure was completed with a different device.No patient complications were 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: 22702136
• Report Number: 2124215-2025-53690
• Device Sequence Number: 8869931
• Product Code: LOX
• UDI-Device Identifier: 08714729370055
• UDI-Public: (01)08714729370055(17)280407(10)36248757
• 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): 09/17/2025

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: H7493892815150
• Device Catalogue Number: H7493892815150
• Device Lot Number: 0036248757
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 09/17/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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: 78 YR
• Patient Sex: Male