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

Model Number	H7493926712350
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
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.Nvestigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis cannot be performed.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there 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.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 most probable investigation conclusion code of cause not established.This conclusion code is based on the available information and the record review conducted at the boston scientific site.Based on the limited available information and lack of procedural detail it cannot be assessed at this time what may have contributed to the reported issue.A review of the product record did not identify any issues during the manufacturing of the finished goods batch which may have contributed to the event.
Event or Problem Description
It was reported that removal difficulty and deflation issue occurred resulting in a prolonged procedure.The patient was being treated for occlusion and underwent an angioplasty procedure.A 3.50mm x 12mm nc emerge balloon catheter was advanced for dilatation.During the procedure, the balloon was inflated inside the patient; however, the balloon could not be deflated, and removal difficulty was experienced.The balloon was removed from the patient in the inflated state.A second 3.50mm x 12mm nc emerge balloon catheter was also advanced; but the same issue occurred, resulting in prolongation of the procedure.There were no patient complications, and the patient 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: 24913617
• Report Number: 2124215-2026-20955
• Device Sequence Number: 9196062
• Product Code: LOX
• UDI-Device Identifier: 08714729846413
• UDI-Public: (01)08714729846413(17)271003(10)37611003
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2026

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 Model Number: H7493926712350
• Device Catalogue Number: H7493926712350
• Device Lot Number: 0037611003
• 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: 03/25/2026
• Initial Report FDA Received Date: 04/17/2026
• Date Device Manufactured: 10/03/2025
• 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
• Patient Sex: Unknown