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

Model Number	H7493912408300
Medical Device Problem Codes	Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
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 100% stenosed target lesion was located in a moderately tortuous and severely calcified coronary artery.An 8mm x 3.00mm nc quantum apex balloon was selected for use.However, it did not cross the lesion.The procedure was completed with another of same device.There were no patient complications.However, returned device analysis revealed balloon torn.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).G4: premarket / 510(k) #: k121667, k160823.Device evaluated by mfr.: nc quantum apex mr 8mm x 3.00mm was returned for analysis.Visual and tactile inspection revealed no issues were identified in the hypotube shaft profile and shaft polymer extrusion profile.A detailed microscopic examination of the balloon material identified a longitudinal tear in the balloon (8mm in length).No issues or damages were identified.A microscopic examination of the proximal and distal markerbands identified no damage.A detailed microscopic examination of the shaft polymer extrusion identified kinks in the inner lumen under the location of the balloon 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: 23554969
• Report Number: 2124215-2025-82109
• Device Sequence Number: 13288862
• Product Code: LOX
• UDI-Device Identifier: 08714729783152
• UDI-Public: 08714729783152
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2025

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: H7493912408300
• Device Catalogue Number: H7493912408300
• Device Lot Number: 0032940587
• 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: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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