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

Model Number	H7493808015350
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 3.5mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, upon unpacking, the balloon ruptured.The device was immediately replaced, and the procedure was completed without any patient complications reported.
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.A 3.5mm x 15mm quantum maverick balloon catheter was advanced for dilation.However, upon unpacking, the balloon ruptured.The device was immediately replaced, and the procedure was completed without any patient complications reported.It was further reported that the balloon ruptured outside the patient's body after the package was opened.The patient remained in stable condition following the procedure.

• 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 ; 7634941632
• MDR Report Key: 22325556
• Report Number: 2124215-2025-41910
• Device Sequence Number: 12998802
• Product Code: LOX
• UDI-Device Identifier: 08714729392804
• UDI-Public: (01)08714729392804(17)261002(10)32554884
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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 Expiration Date: 10/02/2026
• Device Model Number: H7493808015350
• Device Catalogue Number: H7493808015350
• Device Lot Number: 0032554884
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/22/2025
• Date Device Manufactured: 10/03/2023
• 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: 55 YR
• Patient Sex: Male