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

Model Number	H7493926708600
Medical Device Problem Codes	Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation failure occurred.The patient presented with coronary artery disease.The target lesion was located in the non-tortuous and non-calcified left main coronary artery.A 6.00mm x 8mm nc emerge balloon catheter was advanced for post-dilation.The balloon was inflated at 8 atmospheres for 15 seconds.During removal, the balloon was unable to be pulled back into the 7fr guiding catheter despite multiple attempts to apply negative pressure.The balloon remained wedged at the catheter tip, and the physician corked the partially deflated balloon into the guide catheter.Both devices were removed as one unit altogether.No patient complications were reported.
Additional Manufacturer Narrative
D4 batch lot number updated.
Event or Problem Description
It was reported that balloon deflation failure occurred.The patient presented with coronary artery disease.The target lesion was located in the non-tortuous and non-calcified left main coronary artery.A 6.00mm x 8mm nc emerge balloon catheter was advanced for post-dilation.The balloon was inflated at 8 atmospheres for 15 seconds.During removal, the balloon was unable to be pulled back into the 7fr guiding catheter despite multiple attempts to apply negative pressure.The balloon remained wedged at the catheter tip, and the physician corked the partially deflated balloon into the guide catheter.Both devices were removed as one unit altogether.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: fg nc emerge mr, us 6.00mm x 8mm was returned to the complaint investigation site (cis).A visual and tactile inspection with the hypotube profile but no issues identified with the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion identified that the polymer extrusion was stretched throughout its length.A detailed microscopic examination of the balloon material identified a 3mm tear in the mid-section.The bumper distal tip was flared.
Event or Problem Description
It was reported that balloon deflation failure occurred.The patient presented with coronary artery disease.The target lesion was located in the non-tortuous and non-calcified left main coronary artery.A 6.00mm x 8mm nc emerge balloon catheter was advanced for post-dilation.The balloon was inflated at 8 atmospheres for 15 seconds.During removal, the balloon was unable to be pulled back into the 7fr guiding catheter despite multiple attempts to apply negative pressure.The balloon remained wedged at the catheter tip, and the physician corked the partially deflated balloon into the guide catheter.Both devices were removed as one unit altogether.No patient complications were 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; 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: 22572331
• Report Number: 2124215-2025-45000
• Device Sequence Number: 15812222
• Product Code: LOX
• UDI-Device Identifier: 08714729846345
• UDI-Public: (01)08714729846345
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2025

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 Model Number: H7493926708600
• Device Catalogue Number: H7493926708600
• Device Lot Number: 0035505253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 07/24/2025; 08/25/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/21/2025; 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2024
• 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