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

Model Number	H7493892820200
Medical Device Problem Codes	Material Rupture (1546); Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.The 80% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery (lad).A 2.00mm x 20mm maverick 2 balloon catheter was advanced for dilatation.However, during the procedure, at 20 atmospheres, the balloon ruptured.The procedure was completed with another of same device, and no patient complications were reported.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.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.Fg maverick 2 mr, 2.00mm x 20mm was returned for analysis.Visual and tactile inspection of the hypotube revealed multiple kinks.No issues were identified in the shaft polymer extrusion.Microscopic analysis of the balloon showed a longitudinal tear.The distal tip was damaged.The shaft polymer extrusion profile indicated that the inner wire lumen was bunched and stretched in the balloon section which resulted in the proximal section, where the proximal markerband is situated, being pulled distally.A microscopic examination of the markerbands found that the proximal markerband was out of place due to the bunching and stretching of the inner wire lumen inside the balloon.No additional device issues were identified during the returned product analysis.
Event or Problem Description
It was reported that a balloon rupture occurred.The 80% stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery (lad).A 2.00mm x 20mm maverick 2 balloon catheter was advanced for dilatation.However, during the procedure, at 20 atmospheres, the balloon ruptured.The procedure was completed with another of same device, and no patient complications were reported.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: 22414178
• Report Number: 2124215-2025-44174
• Device Sequence Number: 12850279
• Product Code: LOX
• UDI-Device Identifier: 08714729370161
• UDI-Public: (01)08714729370161(17)280220(10)35897996
• 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): 09/16/2025

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: H7493892820200
• Device Catalogue Number: H7493892820200
• Device Lot Number: 0035897996
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 70 YR
• Patient Sex: Male