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

Model Number	H7493926715450
Medical Device Problem Codes	Nonstandard Device (1420); Material Rupture (1546); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 90% stenosed target lesion was located in a non-tortuous and non-calcified coronary artery.A 4.50 mm x 15 mm nc emerge balloon catheter was advanced for post-dilatation.During the initial inflation at 6 atmospheres for 3 seconds, the balloon came into contact with the proximal end of a previously implanted stent, resulting in balloon rupture.The device was removed, and the procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a non-tortuous and non-calcified coronary artery.A 4.50 mm x 15 mm nc emerge balloon catheter was advanced for post-dilatation.During the initial inflation at 6 atmospheres for 3 seconds, the balloon came into contact with the proximal end of a previously implanted stent, resulting in balloon rupture.The device was removed, and the procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.Device evaluated by mfr: fg nc emerge mr, us 4.50mm x 15mm catheter was returned for analysis.A visual and tactile inspection identified multiple hypotube kinks, and no issues identified on the shaft polymer extrusion.A microscopic examination of the balloon material identified a circumferential tear in the mid-section of balloon body.Distal tip showed no signs of damage.A microscopic examination of the distal and proximal markerbands identified no damage.No other device issues were identified during returned product analysis.

• Brand Name: NC EMERGE
• 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: 23303563
• Report Number: 2124215-2025-72492
• Device Sequence Number: 4863831
• Product Code: LOX
• UDI-Device Identifier: 08714729846574
• UDI-Public: (01)08714729846574(17)261202(10)35395112
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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: H7493926715450
• Device Catalogue Number: H7493926715450
• Device Lot Number: 0035395112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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