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

Model Number	H7493912415400
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4 premarket / 501(k): k160823.
Event or Problem Description
It was reported that balloon rupture occurred.An nc quantum apex 15 x 4.00mm was selected for treatment of the target lesion.It was discovered that the balloon could not be inflated as the balloon had already burst.The procedure was completed using another different device and there were no patient complications.
Event or Problem Description
It was reported that balloon rupture occurred.An nc quantum apex 15 x 4.00mm was selected for treatment of the target lesion.It was discovered that the balloon could not be inflated as the balloon had already burst.The procedure was completed using another different device and there were no patient complications.
Additional Manufacturer Narrative
G4 premarket / 501(k): k160823.Device evaluation by mfr: the device was not returned to the complaint investigation site for analysis.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the event.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.A risk review was performed, and it confirmed that this event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.One possibility is that the balloon burst occurred as a result of an unintentional handling error during removal of the device from its packaging, given that the balloon appeared already burst upon opening the package and before any inflation attempts were made.However, as the device did not return for analysis the reported allegation cannot be confirmed.This investigation is assigned a most probable investigation conclusion code of cause not 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: 24272249
• Report Number: 2124215-2026-06569
• Device Sequence Number: 15939696
• Product Code: LOX
• UDI-Device Identifier: 08714729783411
• UDI-Public: (01)08714729783411(17)280707(10)36913816
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2026

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: H7493912415400
• Device Catalogue Number: H7493912415400
• Device Lot Number: 0036913816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 07/08/2025
• 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: Unknown