MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Quantum? Maverick?; catheters, transluminal coronary angioplasty, percutaneous

Model Number	H7493808012300
Medical Device Problem Codes	Material Rupture (1546); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.A 3.00 mm x 12 mm quantum maverick was selected for use.The balloon was advanced to the target lesion and inflated once at 12 atm for 5 to 10 seconds.During inflation, the balloon ruptured, resulting in improper deflation of the device.The device was successfully removed from the patient, and the procedure was completed with another same device.
Additional Manufacturer Narrative
E1 initial reporter facility: (b)(6).E1 initial reporter phone: (b)(6).

• Brand Name: Quantum? 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 ; +1(612)875-7234
• MDR Report Key: 50800566
• Report Number: 2124215-2026-49607
• Device Sequence Number: 8652940
• Product Code: LOX
• UDI-Device Identifier: 08714729392675
• UDI-Public: (01)08714729392675(17)281016(10)37725903
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P860019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: H7493808012300
• Device Catalogue Number: H7493808012300
• Device Lot Number: 0037725903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 10/17/2025
• 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 Sex: Unknown