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

Model Number	6530
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending (lad) artery.An 8mm x 3.00mm nc quantum apex balloon catheter was advanced for dilatation.However, during the first inflation at 12 atmospheres for 5 seconds, the balloon ruptured.The device was successfully removed and no fragments were left inside the patient.The procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device nc quantum apex mr 8mm x 3.00mm was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.No issues were noted with the hypotube shaft and no kinks or damages were also noted.A detailed microscopic examination of the balloon material identified a 7mm longitudinal tear across balloon.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.No other device issues were identified during returned product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified left anterior descending (lad) artery.An 8mm x 3.00mm nc quantum apex balloon catheter was advanced for dilatation.However, during the first inflation at 12 atmospheres for 5 seconds, the balloon ruptured.The device was successfully removed and no fragments were left inside the patient.The procedure was completed.No patient complications were reported.

• 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: 18961254
• Report Number: 2124215-2024-17395
• Device Sequence Number: 8126301
• Product Code: LOX
• UDI-Device Identifier: 08714729783152
• UDI-Public: 08714729783152
• 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): 12/19/2025

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 Expiration Date: 06/24/2026
• Device Model Number: 6530
• Device Catalogue Number: 6530
• Device Lot Number: 0031890406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2023
• 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 Sex: Unknown