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

Model Number	H7493926715250
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event happened during a cto [chronic total occlusion] case performed in cath lab b.We had crossed a wire through a graft leading into the rca [right coronary artery].Then a balloon was placed over the wire and later broke off and dislodged in the vessel.We deployed a stent in the proximity of the balloon to secure it in place.

• Brand Name: NC EMERGE®
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 8 industrial dr.; coventry RI 02816
• MDR Report Key: 25111496
• Report Number: 25111496
• Device Sequence Number: 15784471
• Product Code: LOX
• UDI-Device Identifier: 08714729846505
• UDI-Public: (01)08714729846505
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/17/2026
• Report Date (Section F): 04/17/2026

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: H7493926715250
• Device Catalogue Number: H7493926715250
• Device Lot Number: 36118847
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 04/17/2026