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

Model Number	H7493912412300
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G4: premarket / 510(k) #: k160823.
Event or Problem Description
It was reported that tip detachment occurred.The patient presented with coronary heart disease.A 12 x 3.00 mm nc quantum apex was selected for percutaneous coronary intervention (pci).No damage was observed during unpacking or preparation, and the device advanced smoothly over the wire and guidewire.During the procedure, the balloon tip detached from the catheter.It was successfully retrieved by using a second balloon to extract it from the patient.The procedure successfully completed and there was no patient complication.
Event or Problem Description
It was reported that tip detachment occurred.The patient presented with coronary heart disease.A 12 x 3.00 mm nc quantum apex was selected for percutaneous coronary intervention (pci).No damage was observed during unpacking or preparation, and the device advanced smoothly over the wire and guidewire.During the procedure, the balloon tip detached from the catheter.It was successfully retrieved by using a second balloon to extract it from the patient.The procedure successfully completed and there was no patient complication.
Additional Manufacturer Narrative
G4: premarket / 510(k) #: k160823.Device evaluated by manufacturer: nc quantum apex device was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination identified multiple kinks along the length of the hypotube shaft.There was a break in the midshaft with the core wire exposed.The midshaft was not returned with the device.The polymer extrusion appears to have been cut with only a partial section of the extrusion returned (approximately 5.1cm of it when measured from the distal tip).A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.Bumper tip showed no signs of distal tip damage.The event may have been indicating a polymer extrusion break rather than a tip detachment, but this cannot be confirmed.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 22864692
• Report Number: 2124215-2025-58697
• Device Sequence Number: 18054881
• Product Code: LOX
• UDI-Device Identifier: 08714729783268
• UDI-Public: (01)08714729783268(17)280605(10)36694096
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 11/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493912412300
• Device Catalogue Number: H7493912412300
• Device Lot Number: 0036694096
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown