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

Model Number	H7493912415270
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket / 510(k): k160823.Device evaluated by mfr.: the nc quantum apex mr 15 mm x 2.75 mm was returned to the complaint investigation site.Visual and tactile examination identified multiple hypotube kinks.A break was identified in the inner lumen under the balloon section near the distal tip.The broken distal section did not return.A tear was identified in the balloon material and the torn distal section did not return.A detailed microscopic examination of the balloon material noted a circumferential balloon tear 22.7cm from the port exchange and the distal section was not returned.The distal section of the device did not return.
Event or Problem Description
Reportable based on device analysis completed on 30jun2025.It was reported that crossing difficulties were encountered.The 90% stenosed target lesion was located in the severely tortuous and moderately calcified segment of a chronic totally occluded artery.A 15 mm x 2.75 mm nc quantum apex balloon catheter was advanced but failed to cross the lesion.The procedure was successfully completed with a different device.No patient complications were reported.However, returned device analysis revealed balloon torn circumferential.

• 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: 22510629
• Report Number: 2124215-2025-47193
• Device Sequence Number: 8788511
• Product Code: LOX
• UDI-Device Identifier: 08714729783367
• UDI-Public: (01)08714729783367(17)270315(10)33639484
• 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): 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: H7493912415270
• Device Catalogue Number: H7493912415270
• Device Lot Number: 0033639484
• 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: 06/30/2025
• Initial Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• 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