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

Model Number	H7493912415350
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left circumflex coronary artery.Physician pre-dilated with a 2.0 sc balloon then took a 15mm x 3.50mm nc quantum apex balloon catheter.However, the balloon got burst at 11 atmospheres due to calcification.The procedure was completed via alternative method.There were no patient complications reported.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.G4: premarket / 510(k) #: k121667, k160823.Device evaluated by mfr.: nc quantum apex mr 15mm x 3.50mm was returned for analysis.Visual and tactile inspection revealed no issues with the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion found no issues.A detailed microscopic examination of the balloon material identified a longitudinal tear in the distal section.Bumper tip showed no signs of distal tip damage.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left circumflex coronary artery.Physician pre-dilated with a 2.0 sc balloon then took a 15mm x 3.50mm nc quantum apex balloon catheter.However, the balloon got burst at 11 atmospheres due to calcification.The procedure was completed via alternative method.There were no patient complications 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: 21610213
• Report Number: 2124215-2025-16056
• Device Sequence Number: 7614595
• Product Code: LOX
• UDI-Device Identifier: 08714729783398
• UDI-Public: 08714729783398
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: H7493912415350
• Device Catalogue Number: H7493912415350
• Device Lot Number: 0034094220
• 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: 03/03/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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