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); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).G4 - premarket: k160823.
Event or Problem Description
It was reported that tip detachment occurred.During preparation of the 20mm x 2.75mm nc quantum apex? balloon catheter, no resistance was encountered while removing the balloon protector/mandrel but afterward, it was noted that the tip of the device was broken.The procedure was completed with a different device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
(b)(6).G4 - premarket: k160823.The nc quantum apex mr 20mm x 2.75mm was returned for analysis in three sections.A visual and tactile examination of the hypotube shaft identified a break at 3cm distal to the distal end of the strain relief.A second break was noted at 93.5cm proximal to the guidewire exchange port.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Microscopic inspection revealed no issues with the balloon material or tip.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.
Event or Problem Description
It was reported that tip detachment occurred.During preparation of the 20mm x 2.75mm nc quantum apex? balloon catheter, no resistance was encountered while removing the balloon protector/mandrel but afterward, it was noted that the tip of the device was broken.The procedure was completed with a different device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
E1 - initial reporter city: (b)(6).G4 - premarket: k160823.The nc quantum apex mr 20mm x 2.75mm was returned for analysis in three sections.A visual and tactile examination of the hypotube shaft identified a break at 3cm distal to the distal end of the strain relief.A second break was noted at 93.5cm proximal to the guidewire exchange port.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Microscopic inspection revealed no issues with the balloon material or tip.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.
Event or Problem Description
It was reported that tip detachment occurred.During preparation of the 20mm x 2.75mm nc quantum apex? balloon catheter, no resistance was encountered while removing the balloon protector/mandrel but afterward, it was noted that the tip of the device was broken.The procedure was completed with a different device.There were no patient complications reported and the patient status was stable.
Additional Manufacturer Narrative
A2 age at time of event, a2 unit of measure - age, a3a sex, a3b gender: corrected e1 - initial reporter city: (b)(6).G4 - premarket: k160823 the nc quantum apex mr 20mm x 2.75mm was returned for analysis in three sections.A visual and tactile examination of the hypotube shaft identified a break at 3cm distal to the distal end of the strain relief.A second break was noted at 93.5cm proximal to the guidewire exchange port.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.Microscopic inspection revealed no issues with the balloon material or tip.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.
Event or Problem Description
It was reported that tip detachment occurred.During preparation of the 20mm x 2.75mm nc quantum apex? balloon catheter, no resistance was encountered while removing the balloon protector/mandrel but afterward, it was noted that the tip of the device was broken.The procedure was completed with a different device.There were no patient complications reported and the patient status was stable.

• 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: 22849498
• Report Number: 2124215-2025-57805
• Device Sequence Number: 8421573
• Product Code: LOX
• UDI-Device Identifier: 08714729783473
• UDI-Public: (01)08714729783473(17)261113(10)32847148
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• 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,Followup,Followup,Followup
• Report Date (Section B): 02/25/2026

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: 0032847148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 10/15/2025; 11/02/2025; 02/17/2026
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 10/23/2025; 11/25/2025; 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• 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
• Patient Weight: 65 KG