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

Model Number	H7493912408350
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient was undergoing percutaneous transluminal coronary angioplasty.The target lesion was located in the left anterior descending artery.After a 6f non-boston scientific (bsc) guide catheter was engaged coaxially and a non-bsc guidewire was crossed the lesion, pre-dilation was performed with 2.50 x 15mm semi compliant balloon catheter.A 3.00 x 32mm synergy shield drug-eluting stent was advanced and deployed.Post-deployment, an 8mm x 3.50mm nc quantum apex balloon catheter was advanced for post-dilatation.However, while loading on wire, the shaft was broken.Another 3.50mm x 8mm nc balloon catheter was used to post-dilate the lesion and the procedure was completed.There were no patient complications and the patient fully recovered.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter city: (b)(6).G4: premarket / 510(k) #: k160823.Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis cannot be performed.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.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 investigation conclusion code of cause not established.This code was selected as the most probable complaint cause based on the information available.Based on the limited complaint information and the fact that no device was received for analysis, it is not possible to establish what the cause of the complaint was.

• 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(612)875-7234
• MDR Report Key: 25116438
• Report Number: 2124215-2026-24861
• Device Sequence Number: 10338984
• Product Code: LOX
• UDI-Device Identifier: 08714729783176
• UDI-Public: (01)08714729783176(17)280728(10)37081171
• 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,Followup
• Report Date (Section B): 09/24/2026

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: H7493912408350
• Device Catalogue Number: H7493912408350
• Device Lot Number: 0037081171
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2026
• 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: 04/14/2026
• Supplement Date Received by Manufacturer: 06/09/2026; 09/03/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/24/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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