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

Model Number	H7493926720300
Medical Device Problem Codes	Nonstandard Device (1420); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
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 rupture, removal difficulty, and tip detachment occurred requiring additional intervention.The procedure was performed under conscious sedation.The 100% stenosed target lesion was located in the severely calcified peroneal artery.After initial dilation with a series of compliant balloons, a 3.00 mm x 20 mm nc emerge balloon catheter was advanced for further dilation.During the third inflation at 20 atmospheres for 40 seconds, the balloon ruptured.Some resistance was encountered during withdrawal, and once removed, the tip of the catheter was found to be sheared off, leaving the marker and a portion of the catheter inside the patient.The physician attempted retrieval using a smaller balloon but was unsuccessful.The procedure was performed over a 0.014-inch non-boston scientific guidewire, as the artery was already occluded.The procedure was subsequently aborted due to the inability to open the diseased vessel.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture, removal difficulty, and tip detachment occurred requiring additional intervention.The procedure was performed under conscious sedation.The 100% stenosed target lesion was located in the severely calcified peroneal artery.After initial dilation with a series of compliant balloons, a 3.00 mm x 20 mm nc emerge balloon catheter was advanced for further dilation.During the third inflation at 20 atmospheres for 40 seconds, the balloon ruptured.Some resistance was encountered during withdrawal, and once removed, the tip of the catheter was found to be sheared off, leaving the marker and a portion of the catheter inside the patient.The physician attempted retrieval using a smaller balloon but was unsuccessful.The procedure was performed over a 0.014-inch non-boston scientific guidewire, as the artery was already occluded.The procedure was subsequently aborted due to the inability to open the diseased vessel.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.Device evaluated by mfr: fg nc emerge mr, us 3.00mm x 20mm was returned for analysis.A visual and tactile examination identified multiple kinks along the length of the hypotube shaft.A visual inspection of the outer and inner lumen and tactile examination of the entire extrusion identified a break at the distal end of the device.Microscopic examination identified a complete circumferential tear in the balloon material.Microscopic examination identified a break in the inner lumen 21.6cm distal to the port exchange with the detached portion of the device not returned (including the distal balloon material and tip).Media inspection was performed where two images were provided which show a partial device with a break in the balloon material and detachment of the distal end of the device including the tip.This returned media can confirm the reported allegation.

• 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: 23572344
• Report Number: 2124215-2025-82755
• Device Sequence Number: 10272706
• Product Code: LOX
• UDI-Device Identifier: 08714729846659
• UDI-Public: (01)08714729846659(17)270410(10)36271967
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493926720300
• Device Catalogue Number: H7493926720300
• Device Lot Number: 0036271967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown