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

Model Number	H7493912412250
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The 12 x 2.50 mm nc quantum apex mr balloon catheter was selected for use.While a wire was being advanced through the balloon, a hole between the in and exit port was observed, through which the guidewire was exiting.The procedure was completed with another balloon.There were no patient complications and the patient fully recovered.
Additional Manufacturer Narrative
G4: pma/510(k): k121667, k160823.
Additional Manufacturer Narrative
G4 pma/510(k): k121667, k160823.Investigation results: media review: a doctors notification letter was attached to the complaint record.Device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record review: this device met manufacturing specification prior to distribution and there were 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 product investigation is assigned the most probable cause classification of cause not established based on the limited complaint information and the fact that no device was received for analysis.This code was selected as the most probable complaint cause based on the information available and the investigation conducted.It is possible that an interaction occurred when attempting to load the guidewire which potentially caused the guidewire to puncture through the shaft.However, based on the information provided and without the availability of the device for analysis a clear conclusion cannot be established.
Event or Problem Description
It was reported that a catheter issue occurred.The 12 x 2.50 mm nc quantum apex mr balloon catheter was selected for use.While a wire was being advanced through the balloon, a hole between the in and exit port was observed, through which the guidewire was exiting.The procedure was completed with another balloon.There were no patient complications and the patient fully recovered.

• 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: 24506115
• Report Number: 2124215-2026-11816
• Device Sequence Number: 10486722
• Product Code: LOX
• UDI-Device Identifier: 08714729783244
• UDI-Public: (01)08714729783244(17)280609(10)36717933
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Report Date (Section B): 03/31/2026

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: H7493912412250
• Device Catalogue Number: H7493912412250
• Device Lot Number: 0036717933
• 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: 02/13/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 06/10/2025
• 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 Age: 65 YR
• Patient Sex: Female