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

Model Number	H7493912408350
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket / 510(k) #: k160823.
Event or Problem Description
It was reported that balloon ruptured occurred.The patient, diagnosed with coronary artery disease (cad), was admitted for cardiac catheterization to undergo percutaneous transluminal coronary angioplasty (ptca).A 90% stenosed target lesion was identified in a moderately tortuous and moderately calcified coronary artery.The procedure began with cannulation of the artery using a 3.5 mach fr catheter.The samurai coronary guide was then advanced, and an 8mm x 3.5mm nc quantum apex balloon catheter was selected for the intervention.However, while attempting to advance the balloon through the guide catheter, the proximal segment of the balloon ruptured.The device was removed, and the procedure was completed with a different device.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: 21602018
• Report Number: 2124215-2025-15849
• Device Sequence Number: 4431210
• Product Code: LOX
• UDI-Device Identifier: 08714729783176
• UDI-Public: 08714729783176
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 03/13/2025

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: H7493912408350
• Device Catalogue Number: H7493912408350
• Device Lot Number: 0034334177
• 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: 02/26/2025
• Initial Report FDA Received Date: 03/13/2025
• Date Device Manufactured: 06/28/2024
• 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