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

Model Number	H7493926712300
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
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 that shaft break occurred requiring additional intervention occurred.The 100 % stenosed target lesion was located in the right coronary artery.A 3.00mm x 12mm nc emerge balloon catheter.However, after a series of ten inflations, sudden loss of pressure movement of the shaft was observed during balloon withdrawal while the balloon remained in place, and the shaft was fractured.The balloon was subsequently retracted into the guide, and the tip of the guidewire was monitored under fluoroscopy during removal.Upon removal of the guide, the balloon markers were noted within the radial sheath.A guidewire and a new 2.0 x 8 balloon were advanced and inflated to secure the detached balloon segment.The sheath, wire, balloon, and fractured shaft were all removed from the body.A tr (transradial band) band was applied.No patient complications, and the patient has fully recovered.
Additional Manufacturer Narrative
Media analysis: an image was provided which show the devices the device in two pieces.It appears that there is extensive stretching in the distal polymer extrusion, a break in the inner lumen of the device and that there is a complete circumferential tear in the balloon material.This provided image can confirm the complaint allegations.
Event or Problem Description
It was reported that shaft break occurred requiring additional intervention occurred.The 100 % stenosed target lesion was located in the right coronary artery.A 3.00mm x 12mm nc emerge balloon catheter.However, after a series of ten inflations, sudden loss of pressure movement of the shaft was observed during balloon withdrawal while the balloon remained in place, and the shaft was fractured.The balloon was subsequently retracted into the guide, and the tip of the guidewire was monitored under fluoroscopy during removal.Upon removal of the guide, the balloon markers were noted within the radial sheath.A guidewire and a new 2.0 x 8 balloon were advanced and inflated to secure the detached balloon segment.The sheath, wire, balloon, and fractured shaft were all removed from the body.A tr (transradial band) band was applied.No patient complications, and the patient has fully recovered.

• 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: 23984295
• Report Number: 2124215-2026-00801
• Device Sequence Number: 11903514
• Product Code: LOX
• UDI-Device Identifier: 08714729846390
• UDI-Public: (01)08714729846390(17)270430(10)36408261
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• Report Date (Section B): 02/18/2026

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: H7493926712300
• Device Catalogue Number: H7493926712300
• Device Lot Number: 0036408261
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 01/06/2026
• Supplement Report FDA Received Date: 02/18/2026
• Date Device Manufactured: 04/30/2025
• 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
• Patient Sex: Unknown