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

Model Number	H7493892815200
Medical Device Problem Codes	Nonstandard Device (1420); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a severely tortuous and severely calcified left anterior descending artery.A 2.00mm x 15mm maverick? balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured.The procedure was completed with a different device without any patient complications reported.The patient was in good condition.
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.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a severely tortuous and severely calcified left anterior descending artery.A 2.00mm x 15mm maverick? balloon catheter was advanced for dilatation.However, during the procedure, the balloon ruptured.The procedure was completed with a different device without any patient complications reported.The patient was in good condition.
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.Device evaluated by mfr.: the fg maverick 2 mr, 2.00mm x 15mm catheter was returned for analysis.A visual and tactile examination of the hypotube noted multiple kinks along its length, and no kinks or damages on the shaft polymer extrusion.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.Tip showed no signs of tip damage.Leakage testing was performed where the device was attached to an encore inflation unit.The balloon was inflated to its rated burst pressure (rbp) of 12 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.No issues were identified with balloon inflation or the balloon material.

• 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: 23497367
• Report Number: 2124215-2025-77604
• Device Sequence Number: 18359672
• Product Code: LOX
• UDI-Device Identifier: 08714729370062
• UDI-Public: (01)08714729370062(17)280721(10)37025885
• 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): 01/02/2026

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: H7493892815200
• Device Catalogue Number: H7493892815200
• Device Lot Number: 0037025885
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2025
• 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: 67 YR
• Patient Sex: Male