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

Model Number	H7493912420270
Medical Device Problem Codes	Nonstandard Device (1420); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket 501(k): k160823.
Event or Problem Description
It was reported that a detachment occurred.An nc quantum apex mr 2.75 x 20mm was selected for treatment of the target lesion.When removing the balloon from the protector, the physician noted that the balloon was cut.There were no patient complications.
Additional Manufacturer Narrative
G4: premarket 501(k): k160823.Device evaluation by mfr: the returned product consisted of the nc quantum apex.A visual inspection showed a break in the shaft polymer extrusion 2mm distal to the prot exchange.The distal section including the balloon was not returned.The exposed core wire in the distal section was also bent.Based on the available information it is likely that this reported damage occurred due to product handling and unintentionally excessive force being applied to the delivery system while unpacking and preparing for the procedure.This investigation is assigned a most probable investigation conclusion code of unintended use error caused or contributed to event.
Event or Problem Description
It was reported that a detachment occurred.An nc quantum apex mr 2.75 x 20mm was selected for treatment of the target lesion.When removing the balloon from the protector, the physician noted that the balloon was cut.There were no patient complications.
Additional Manufacturer Narrative
A correction report is being submitted to capture further investigation information.G4: premarket 501(k): k160823.Device history record review: 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.Device technical analysis: a visual inspection of the device revealed a break in the shaft 2mm distal to the port exchange.The distal section including the balloon were not returned.The exposed core wire in the distal section was bent.Labeling review: based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.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 (prr) table.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on the available information it is likely that this reported damage occurred due to product handling and unintentionally excessive force being applied to the delivery system while unpacking and preparing for the procedure.This investigation is assigned a most probable investigation conclusion code of unintended use error caused or contributed to event.
Event or Problem Description
It was reported that a detachment occurred.An nc quantum apex mr 2.75 x 20mm was selected for treatment of the target lesion.When removing the balloon from the protector, the physician noted that the balloon was cut.There were no patient complications.

• 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: 24272187
• Report Number: 2124215-2026-06567
• Device Sequence Number: 10726305
• Product Code: LOX
• UDI-Device Identifier: 08714729783473
• UDI-Public: (01)08714729783473(17)280708(10)36924732
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2026

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: H7493912420270
• Device Catalogue Number: H7493912420270
• Device Lot Number: 0036924732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 03/05/2026; 04/21/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/31/2026; 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• 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