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

Model Number	H7493912408270
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	02/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4 premarket / 510(k): k160823.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Device evaluated by mfr: an nc quantum apex mr 8mm x 2.75mm, catheter was returned for analysis.Visual and tactile inspection revealed no issues identified on the hypotube and shaft polymer extrusion.A microscopic examination of the balloon identified a 1cm longitudinal tear in the mid-section of the balloon material.Distal tip showed no signs of damage.A microscopic examination of the distal and proximal markerbands identified no damage.No other device issues were identified during returned product analysis.
Event or Problem Description
Reportable based on the device analysis completed on 24nov2025.It was reported that crossing difficulties occurred.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.An 8mm x 2.75mm nc quantum apex balloon catheter was advanced for dilation.But the device failed to cross the lesion.The procedure was completed with a non-boston scientific balloon.No patient complications were reported.However, returned device analysis revealed a balloon longitudinal tear.

• 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: 23758669
• Report Number: 2124215-2025-89843
• Device Sequence Number: 10170913
• Product Code: LOX
• UDI-Device Identifier: 08714729783145
• UDI-Public: (01)08714729783145(17)261108(10)32818800
• 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): 12/09/2025

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 Model Number: H7493912408270
• Device Catalogue Number: H7493912408270
• Device Lot Number: 0032818800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• 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 Sex: Male