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

Model Number	H7493912408450
Medical Device Problem Codes	Nonstandard Device (1420); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with double vessel disease and underwent percutaneous transluminal coronary angioplasty (ptca).The chronic totally occluded target lesions were located in the right coronary artery (rca) and left main to left anterior descending artery (lmlad).After successful rca intervention, ptca to lmlad was performed under intravascular ultrasound (ivus) guidance by inserting 7f non-boston scientific (bsc) guide catheter.The lesion was crossed with a non-bsc guidewire, and ivus evaluation was done followed by stenting in the lmlad.An 8mm x 4.50mm nc quantum apex? balloon catheter was advanced for post dilation.However, on the first inflation at 6 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
G4 premarket / 510(k): k160823.
Event or Problem Description
It was reported that balloon rupture occurred.The patient presented with double vessel disease and underwent percutaneous transluminal coronary angioplasty (ptca).The chronic totally occluded target lesions were located in the right coronary artery (rca) and left main to left anterior descending artery (lmlad).After successful rca intervention, ptca to lmlad was performed under intravascular ultrasound (ivus) guidance by inserting 7f non-boston scientific (bsc) guide catheter.The lesion was crossed with a non-bsc guidewire, and ivus evaluation was done followed by stenting in the lmlad.An 8mm x 4.50mm nc quantum apex? balloon catheter was advanced for post dilation.However, on the first inflation at 6 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
G4 premarket / 510(k): k160823 investigation results: device analysis findings: the 8mm x 4.50mm nc quantum apex mr balloon catheter was returned for analysis.A visual and tactile examination identified no issues along the length of the hypotube shaft.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues.A detailed microscopic examination of the balloon material identified an 8mm longitudinal tear across the main body of the balloon.The distal bumper tip was deformed.A microscopic examination of the proximal and distal markerbands identified no damage.A leakage test was performed; however, the balloon could not be inflated due to an 8mm longitudinal tear across the main body of the balloon.No other device issues were identified during returned product analysis.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 investigation is assigned a most probable investigation conclusion code of cause not established.This code was selected as the most probable complaint cause based on the information available and the investigation conducted.It was reported that balloon rupture occurred.Device analysis identified an 8mm longitudinal tear across the main body of the balloon and therefore confirming the alleged material rupture.In addition, the distal bumper tip was deformed.Based on the event details, it is possible interactions of the balloon with the lesion's anatomical features, as well as interactions with other ancillary devices used during the procedure led to the material rupture and tip damage.However, based on the available complaint information and condition of the returned device, a clear conclusion cannot be established at this time.

• 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: 22998437
• Report Number: 2124215-2025-62989
• Device Sequence Number: 8806673
• Product Code: LOX
• UDI-Device Identifier: 08714729783206
• UDI-Public: (01)08714729783206(17)280206(10)35793452
• 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): 04/09/2026

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: H7493912408450
• Device Catalogue Number: H7493912408450
• Device Lot Number: 0035793452
• 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: 08/15/2025
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• 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
• Patient Age: 74 YR
• Patient Sex: Male