MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC Quantum Apex?; catheters, transluminal coronary angioplasty, percutaneous

Model Number	H7493912412250
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4 - premarket: 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.
Event or Problem Description
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in a moderately tortuous and moderately calcified left anterior descending artery.After a non-bsc guidewire crossed the lesion, pre-dilatation was performed with a 12mm x 2.50mm nc quantum apex? balloon catheter.However, during the first inflation at 10 atmospheres, the balloon ruptured.The device was completely removed and the procedure was completed with another 2.50 x 15 mm nc quantum apex balloon.There were no patient complications reported.

• 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 ; +1(763)494-1632
• MDR Report Key: 23387944
• Report Number: 2124215-2025-76741
• Device Sequence Number: 8718000
• Product Code: LOX
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K121667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2026

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: H7493912412250
• Device Catalogue Number: H7493912412250
• Device Lot Number: 0034804163
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/21/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 10/26/2025
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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 Age: 69 YR
• Patient Sex: Male