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

Model Number	H7493808012350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the right coronary artery.A 3.5mm x 12mm quantum maverick balloon catheter was advanced for dilation.However, the balloon delivery shaft was fractured, and the fractured part was removed from the patient.The procedure was completed with another of same device.There were no patient complications.Patient was stable.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in the right coronary artery.A 3.5mm x 12mm quantum maverick balloon catheter was advanced for dilation.However, the balloon delivery shaft was fractured, and the fractured part was removed from the patient.The procedure was completed with another of same device.There were no patient complications.Patient was stable.
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr.: fg quantum maverick, mr 3.5mm x 12mm was returned for analysis.Visual and tactile inspection identified a break in the hypotube 53cm distal to the distal end of the strain relief.No issues identified in the shaft polymer extrusion profile.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.Distal tip showed no signs of damage.A single device image was returned with this complaint of the device looped inside the inner pouch with a clear view of the reported shaft break.

• 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: 23442114
• Report Number: 2124215-2025-77827
• Device Sequence Number: 14648354
• Product Code: LOX
• UDI-Device Identifier: 08714729392699
• UDI-Public: (01)08714729392699(17)280205(10)35782902
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2026

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: H7493808012350
• Device Catalogue Number: H7493808012350
• Device Lot Number: 0035782902
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 01/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 65 KG