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

Model Number	H7493926720200
Medical Device Problem Codes	Nonstandard Device (1420); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
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.
Event or Problem Description
It was reported that balloon detachment occurred.A 2.00mm x 20mm nc emerge balloon catheter was advanced for dilatation.However, during procedure, the balloon component separated from the shaft.The device was successfully removed, and the procedure was completed using an alternate device.No patient complications were reported.
Event or Problem Description
It was reported that balloon detachment occurred.A 2.00mm x 20mm nc emerge balloon catheter was advanced for dilatation.However, during procedure, the balloon component separated from the shaft.The device was successfully removed, and the procedure was completed using an alternate device.No patient complications were reported.
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.Investigation results: device analysis findings: the 2.00mm x 20mm fg nc emerge mr balloon catheter was returned for analysis.A visual and tactile inspection identified multiple kinks along the hypotube shaft.The balloon was subjected to positive pressure and returned in a deflated state.A visual, tactile, and microscopic inspection identified a complete circumferential tear, 22.6cm from the port exchange with the distal section returned bunched together.A break was identified within the shaft polymer extrusion.The inner shaft polymer extrusion was detached, 20cm from the port exchange with a small section, 7.2cm in length of the inner shaft returned stretched.The inner shaft polymer extrusion was also stretched and detached just proximal from the bumper tip.No issues were noted with the bumper tip.The distal and proximal markerbands were not attached or returned with the balloon catheter.No other device issues were identified during returned product analysis.Device history record review: it was confirmed that this device met manufacturing specification prior to distribution and there were 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 conclusion code of cause not established.This conclusion code is selected based on the available information as well as the condition of the device when analyzed.It was reported that balloon detachment occurred.The device was advanced for dilatation however during the procedure, the balloon component had separated from the shaft.Returned device analysis confirmed the reported allegation.A complete circumferential tear was identified on the balloon profile with the distal section bunched together.The inner shaft polymer extrusion was stretched and detached from the dilation catheter.These findings are consistent with a tensile event resulting in shaft damages and subsequent balloon detachment.Due to limited procedural information, the condition of the returned device and without any procedural media, the cause for the reported event cannot be determined.

• 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: 24146706
• Report Number: 2124215-2026-04050
• Device Sequence Number: 13095149
• Product Code: LOX
• UDI-Device Identifier: 08714729846611
• UDI-Public: (01)08714729846611(17)260508(10)33986508
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/25/2026

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: 05/08/2026
• Device Model Number: H7493926720200
• Device Catalogue Number: H7493926720200
• Device Lot Number: 0033986508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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 Age: 82 YR
• Patient Sex: Male
• Patient Race: White