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

Model Number	H7493926712300
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Codes	Non specific EKG/ECG Changes (1817); Foreign Body In Patient (2687)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that removal difficulty occurred resulting in additional intervention.The 3.00mm x 12mm nc emerge balloon catheter was selected for use.During the procedure, the balloon got snared on a stent and the distal end of the catheter sheared off in the vessel.Attempts were made to snare the broken piece, but they were unsuccessful.St segment elevation was noted, and the patient was admitted to the hospital.The physician remarked that the patient would likely lose that diagonal artery.Additional information has been requested but not yet received.
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 removal difficulty occurred resulting in additional intervention.The 3.00mm x 12mm nc emerge balloon catheter was selected for use.During the procedure, the balloon got snared on a stent and the distal end of the catheter sheared off in the vessel.Attempts were made to snare the broken piece, but they were unsuccessful.St segment elevation was noted, and the patient was admitted to the hospital.The physician remarked that the patient would likely lose that diagonal artery.Additional information has been requested but not yet received.
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.Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record review: this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation and is recorded accordingly in the product record review.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this product investigation is assigned the most probable cause classification of cause not established.This code was selected as the most probable complaint cause based on the information available and the investigation conducted.Based on the event details, it is possible that interactions of the balloon with the implanted stent contributed to the reported removal difficulties which potentially resulted in the detachment of device, unretrieved device fragments (udf), additional device required, hospitalization and st segment elevation.However, based on the complaint information provided, without the availability of media and the fact that no device was received for analysis, a definitive conclusion cannot be established with certainty.

• 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: 24520524
• Report Number: 2124215-2026-12302
• Device Sequence Number: 13184529
• Product Code: LOX
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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: 0036798481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 05/08/2026
• Date Device Manufactured: 06/20/2025
• 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; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male