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

Model Number	H7493912415300
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	02/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket / 510(k) #: k121667, k160823.Device evaluated by mfr.: nc quantum apex mr 15mm x 3.00mm stent delivery system (sds) was returned for analysis.A visual and tactile examination revealed no issues or damages noted in the hypotube.A visual examination of the balloon identified a complete circumferential tear with the distal section not returned.A microscopic examination found a complete circumferential tear was noted in the mid-section of the balloon, 22.6cm from the port exchange with the distal section was not returned.No kinks or damages noted in the shaft polymer extrusion.Bumper tip showed no signs of distal tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.
Event or Problem Description
Reportable based on device analysis completed on 10-jul-2025.It was reported that crossing difficulties were encountered.The 70% stenosed target lesion was located in the severely tortuous and mildly calcified proximal left anterior descending artery.A 15mm x 3.00mm nc quantum apex balloon catheter was advanced for dilation.However, the device could not cross the lesion.The procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed 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: 22513207
• Report Number: 2124215-2025-47379
• Device Sequence Number: 18453368
• Product Code: LOX
• UDI-Device Identifier: 08714729783374
• UDI-Public: 08714729783374
• 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): 07/15/2025

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: H7493912415300
• Device Catalogue Number: H7493912415300
• Device Lot Number: 0033534898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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