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

Model Number	H7493926720350
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event was estimated as the date of event was reported as feb-2026.
Event or Problem Description
It was reported via medsun (b)(4) that balloon rupture occurred and additional intervention was required.The 3.50mm x 20mm nc emerge balloon was selected for use.The balloon ruptured inside the patient due to calcium.Several attempts were made to remove the balloon.An intra-aortic-balloon pump was inserted, and the patient was sent to surgery.
Event or Problem Description
It was reported via medsun (b)(4) that balloon rupture occurred and additional intervention was required.The 3.50mm x 20mm nc emerge balloon was selected for use.The balloon ruptured inside the patient due to calcium.Several attempts were made to remove the balloon.An intra-aortic-balloon pump was inserted, and the patient was sent to surgery.
Additional Manufacturer Narrative
B3 date of event was estimated as the date of event was reported as (b)(6) 2026.Investigation results: device technical analysis: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history review: it was confirmed that this device met manufacturing specification prior to distribution and there are 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.Based on the available information, there was no evidence of device off-label use, or failure to follow the instructions for use (ifu).Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a conclusion code of adverse event related to patient condition due to anatomical factors.This code was selected as the most probable complaint cause based on the information available.Based on the event description, it is likely that the lesion anatomy contributed to the reported event.

• 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: 24457266
• Report Number: 2124215-2026-10758
• Device Sequence Number: 9969314
• Product Code: LOX
• UDI-Device Identifier: 08714729846673
• UDI-Public: (01)08714729846673(17)270908(10)37393588
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2026

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: H7493926720350
• Device Catalogue Number: H7493926720350
• Device Lot Number: 0037393588
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 02/26/2026
• Supplement Report FDA Received Date: 04/20/2026
• Date Device Manufactured: 09/08/2025
• 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