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

Model Number	6530
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 22-oct-2025.It was reported that crossing difficulties were encountered.The 90% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.Pre-dilatation was performed with a smaller size of non-compliant balloon, and an 8mm x 4.50mm nc quantum apex balloon catheter was advanced but failed to cross the lesion.The procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed balloon torn longitudinal.
Additional Manufacturer Narrative
E1.Initial reporter address 1: (b)(6).Device evaluated by mfr: nc quantum apex mr 8mm x 4.50mm was returned for analysis.A visual and tactile inspection of hypotube shaft identified no issues.A visual and tactile inspection of shaft polymer extrusion identified no issues, and a microscopic inspection identified a kink in the inner lumen 1mm proximal to the distal markerband under the balloon material.A detailed microscopic examination of the balloon material identified a tear in the balloon in the mid-section.A kink in the distal tip was identified.A microscopic examination of the proximal and distal markerbands identified no damage.

• 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 ; 7634941632
• MDR Report Key: 23519978
• Report Number: 2124215-2025-81773
• Device Sequence Number: 18568016
• Product Code: LOX
• UDI-Device Identifier: 08714729783206
• UDI-Public: 08714729783206
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121667
• 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
• Report Date (Section B): 11/11/2025

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: 10/12/2025
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0030334780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2022
• 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: 77 YR
• Patient Sex: Female