MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NC Emerge; catheters, transluminal coronary angioplasty, percutaneous

Model Number	7211
Medical Device Problem Codes	Nonstandard Device (1420); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 3.50mm x 8mm fg nc emerge balloon catheter was advanced for dilation.However, during inflation, it was noted that the balloon burst.The balloon was removed and completed with a different device.There were no patient complications reported.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(763)494-1632
• MDR Report Key: 18849933
• Report Number: 2124215-2024-12062
• Device Sequence Number: 7439335
• Product Code: LOX
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2026

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 Expiration Date: 06/25/2025
• Device Model Number: 7211
• Device Catalogue Number: 7211
• Device Lot Number: 0031891415
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/16/2026
• 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: 02/11/2024
• Supplement Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• 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
• Patient Sex: Unknown