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

Model Number	7214
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft hole occurred.The target lesion was located in a coronary artery.A 5.00mm x 20mm nc emerge balloon catheter was advanced onto the guidewire.However, it was noted the guidewire exited distal to the monorail exit port.The balloon was removed and completed the procedure with another 5.0 x 20mm nc emerge.There were no patient complications.
Event or Problem Description
It was reported that shaft hole occurred.The target lesion was located in a coronary artery.A 5.00mm x 20mm nc emerge balloon catheter was advanced onto the guidewire.However, it was noted the guidewire exited distal to the monorail exit port.The balloon was removed and completed the procedure with another 5.0x20mm nc emerge.There were no patient complications.
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was not returned for analysis as it was disposed; therefore, a technical analysis could not 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 and is recorded accordingly in the product record review table.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 unintended use error caused or contributed to event.This code was selected as the most probable complaint cause based on the information available.It was reported that a shaft hole occurred.It was noted that the guidewire exited distal to the monorail exit port.The device was disposed of.The reported event cannot be confirmed.Based on the event description, the reported shaft hole likely occurred when loading the guidewire where an excessive force was applied to cause the guidewire to pierce the shaft polymer extrusion.Labelling indication states to carefully backload the guidewire onto the device.

• 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: 24651066
• Report Number: 2124215-2026-15549
• Device Sequence Number: 9786940
• Product Code: LOX
• UDI-Device Identifier: 08714729846710
• UDI-Public: (01)08714729846710(17)271009(10)37660219
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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
• Report Date (Section B): 04/22/2026

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: 7214
• Device Catalogue Number: 7214
• Device Lot Number: 0037660219
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/22/2026
• Date Device Manufactured: 10/09/2025
• 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 Age: 71 YR
• Patient Sex: Male