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

Model Number	H7493926715300
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/21/2025
Type of Reportable Event	Serious Injury
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 via user facility report (b)(4) that balloon detachment occurred.The target lesion was located in the circumflex coronary artery.A 3.00mm x 15mmm nc emerge balloon catheter was advanced for dilatation.During the angioplasty procedure, the balloon detached into the coronary artery.No further information available.
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 via user facility report (b)(4) that balloon detachment occurred.The target lesion was located in the circumflex coronary artery.A 3.00mm x 15mmm nc emerge balloon catheter was advanced for dilatation.During the angioplasty procedure, the balloon detached into the coronary artery.No further information available.It was further reported that the lesion exhibited some tortuosity.The balloon was inflated three or more times, and the balloon material detaching from the shaft.Because the detached material was not visible on the angiogram, it could not be removed, and stents were deployed to secure the balloon material against the vessel wall.
Event or Problem Description
It was reported that balloon detachment occurred.The target lesion was located in the circumflex coronary artery.A 3.00mm x 15mmm nc emerge balloon catheter was advanced for dilatation.During the angioplasty procedure, the balloon detached into the coronary artery.No further information available.It was further reported that the lesion exhibited some tortuosity.The balloon was inflated three or more times, and the balloon material detaching from the shaft.Because the detached material was not visible on the angiogram, it could not be removed, and stents were deployed to secure the balloon material against the vessel wall.
Additional Manufacturer Narrative
Correction: user facility report reference number removed from b5 describe event or problem.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

• 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; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22866028
• Report Number: 2124215-2025-57733
• Device Sequence Number: 9184907
• Product Code: LOX
• UDI-Device Identifier: 08714729846529
• UDI-Public: (01)08714729846529(17)270210(10)35815166
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493926715300
• Device Catalogue Number: H7493926715300
• Device Lot Number: 0035815166
• 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: 08/13/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 03/26/2026
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/21/2025; 03/26/2026
• Date Device Manufactured: 02/10/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown