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

Model Number	H7493926712270
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that device difficulty removal and shaft break occurred.The 95% stenosed target lesion was located in the severely tortuous and moderately calcified coronary artery.A 6f guidezilla and 2.75mm x 12mm nc emerge balloon was selected for use.During procedure, it was noted that nc emerge was advance into the guidezilla, and after post dilating the stent, resistance was felt while removing the balloon.Furthermore, after taking the balloon out, it was noted that the shaft was broken in two and the non-boston scientific (bsc) 0.014-inch guidewire had sheared off.The device was removed by using another 0.014-inch guidewire and balloon and inflated it to snare or trap the distal balloon shaft in the body.All pieces were removed intact.The procedure was completed with another 2.75 mm x 12mm nc emerge.There were no patient complications.
Additional Manufacturer Narrative
G2 report source: corrected.
Event or Problem Description
It was reported that device difficulty removal and shaft break occurred.The 95% stenosed target lesion was located in the severely tortuous and moderately calcified coronary artery.A 6f guidezilla and 2.75mm x 12mm nc emerge balloon was selected for use.During procedure, it was noted that nc emerge was advance into the guidezilla, and after post dilating the stent, resistance was felt while removing the balloon.Furthermore, after taking the balloon out, it was noted that the shaft was broken in two and the non-boston scientific (bsc) 0.014-inch guidewire had sheared off.The device was removed by using another 0.014-inch guidewire and balloon and inflated it to snare or trap the distal balloon shaft in the body.All pieces were removed intact.The procedure was completed with another 2.75 mm x 12mm nc emerge.There were no patient complications.
Additional Manufacturer Narrative
G2 report source: corrected.Device evaluated by manufacturer: the device was returned for analysis.Media provided by the customer showed a break located in the polymer extrusion.
Event or Problem Description
It was reported that device difficulty removal and shaft break occurred.The 95% stenosed target lesion was located in the severely tortuous and moderately calcified coronary artery.A 6f guidezilla and 2.75mm x 12mm nc emerge balloon was selected for use.During procedure, it was noted that nc emerge was advance into the guidezilla, and after post dilating the stent, resistance was felt while removing the balloon.Furthermore, after taking the balloon out, it was noted that the shaft was broken in two and the non-boston scientific (bsc) 0.014-inch guidewire had sheared off.The device was removed by using another 0.014-inch guidewire and balloon and inflated it to snare or trap the distal balloon shaft in the body.All pieces were removed intact.The procedure was completed with another 2.75 mm x 12mm nc emerge.There were no patient complications.

• 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: 23635712
• Report Number: 2124215-2025-84651
• Device Sequence Number: 10477450
• Product Code: LOX
• UDI-Device Identifier: 08714729846383
• UDI-Public: (01)08714729846383(17)270103(10)35548115
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493926712270
• Device Catalogue Number: H7493926712270
• Device Lot Number: 0035548115
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 11/25/2025; 12/09/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 11/25/2025; 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER GUIDE EXTENSION-GUIDEZILLA.; CATHETER GUIDE EXTENSION-GUIDEZILLA.; CATHETER GUIDE EXTENSION-GUIDEZILLA.; GUIDEWIRE-BMW.; GUIDEWIRE-BMW.; GUIDEWIRE-BMW.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown