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

Model Number	H7493912412350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported shaft break occurred requiring additional intervention.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified proximal right coronary artery.A 12mm x 3.50mm nc quantum apex? balloon catheter was selected for use.However, during the attempts to cross the lesion, it was noticed that the shaft was broken into two pieces.The device was completely removed using snare.The procedure was completed with another 12mm x 3.50mm nc quantum apex mr balloon catheter.No further complications were reported, and the patient status was stable post-procedure.
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).G4 - premarket: k160823.

• Brand Name: NC Quantum Apex?
• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50844363
• Report Number: 2124215-2026-50252
• Device Sequence Number: 18631206
• Product Code: LOX
• UDI-Device Identifier: 08714729783282
• UDI-Public: (01)08714729783282(17)281117(10)37984385
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121667
• 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): 09/21/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493912412350
• Device Catalogue Number: H7493912412350
• Device Lot Number: 0037984385
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 11/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male