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

Model Number	6531
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter first name: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.During unpacking of a 12mm x 2.50mm nc quantum apex balloon catheter, it was found that the shaft was broken.The procedure was completed with another nc quantum apex balloon.No patient complications were reported.
Event or Problem Description
It was reported that shaft break occurred.During unpacking of a 12mm x 2.50mm nc quantum apex balloon catheter, it was found that the shaft was broken.The procedure was completed with another nc quantum apex balloon.No patient complications were reported.It was further reported that the break occurred adjacent to the hub.
Additional Manufacturer Narrative
B5 describe event or problem: updated to include new information obtained.E1: initial reporter first name: (b)(6).
Additional Manufacturer Narrative
B5 - describe event or problem: updated to include new information obtained.E1: initial reporter first name: (b)(6).The device was returned for analysis.Visual, tactile, and microscopic examinations identified multiple kinks and a break in the hypotube shaft, located distal to the distal end of the strain relief.No issues were observed in the shaft polymer extrusion.Microscopic examination of the balloon material indicated that it had been subjected to positive pressure; the balloon was unfolded, and contrast media was visible within it, though no damage to the balloon material was identified.The distal tip was intact with no visible damage.Microscopic evaluation of the proximal and distal marker bands also revealed no damage.A detailed microscopic inspection of the shaft polymer extrusion identified a leak in the midshaft region, approximately the distal tip.Functional testing was performed by attaching the device to an encore inflation unit.During inflation, a leak was observed at the midshaft location, preventing full balloon inflation.The encore inflation unit was verified for proper function before and after testing using a druck gauge.No additional device issues or defects were identified during the returned product analysis.
Event or Problem Description
It was reported that shaft break occurred.During unpacking of a 12mm x 2.50mm nc quantum apex balloon catheter, it was found that the shaft was broken.The procedure was completed with another nc quantum apex balloon.No patient complications were reported.It was further reported that the break occurred adjacent to the hub.

• 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: 19055566
• Report Number: 2124215-2024-19979
• Device Sequence Number: 18184544
• Product Code: LOX
• UDI-Device Identifier: 08714729783244
• UDI-Public: 08714729783244
• 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,Followup
• Report Date (Section B): 11/18/2025

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 Model Number: 6531
• Device Catalogue Number: 6531
• Device Lot Number: 0032642479
• 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: 03/29/2024
• Supplement Date Received by Manufacturer: 04/11/2024; 10/30/2025
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 05/02/2024; 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• 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: 72 YR
• Patient Sex: Male
• Patient Race: Asian