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

Model Number	H7493912408250
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	02/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 05-may-2026.It was reported that crossing difficulties were encountered.The 80% stenosed target lesion was located in a mildly tortuous and severely calcified coronary artery.After 2.00mm and 2.25 mm nc quantum apex balloon catheters crossed the lesion, a 8mm x 2.50mm nc quantum apex balloon catheter failed to cross.The procedure was completed with a non-boston scientific device.There were no patient complications.However, returned device analysis revealed shaft rupture.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).G4: pma/510(k) # field on 3500a form: k121667, k160823.Investigation results: device analysis findings: nc quantum apex mr 8mm x 2.50mm stent delivery system (sds) was returned for analysis.A visual and tactile examination of the hypotube shaft identified no issues.A visual and tactile examination of the outer and inner lumen noted the shaft was ruptured.Balloon material was reviewed.Microscopic examination of the balloon identified no pinholes or tears in the balloon material.Bumper tip showed that the distal bumper tip was slightly flared.A microscopic examination of the proximal and distal markerbands identified no damage.Microscopic examination of the outer and inner lumen noted the shaft was ruptured at 23mm from the tip for 7mm in length.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review table.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a most probable conclusion code of cause not established.This code was selected as the most probable complaint cause based on the information available.It was reported this nc emerge mr, ous 4.00mm x 8mm was selected for treatment.However, it failed to cross the severely calcified lesion.Examination of the outer and inner lumen noted the shaft polymer extrusion was ruptured at 23mm from the tip for 7mm in length.In addition, the distal bumper tip was slightly flared.It is likely that an interaction occurred with the device and the severely calcified lesion which likely contributed to the unreported tip damage.Based on the complaint information available and considering the condition of the returned device a clear cause for the reported event could not be established.

• 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: 25293223
• Report Number: 2124215-2026-28285
• Device Sequence Number: 21144497
• Product Code: LOX
• UDI-Device Identifier: 08714729783138
• UDI-Public: 08714729783138
• 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): 05/26/2026

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: H7493912408250
• Device Catalogue Number: H7493912408250
• Device Lot Number: 0033745403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• 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