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

Model Number	H7493926712300
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon detachment and balloon rupture occurred requiring treatment.The target lesion was located in the non-tortuous and moderately calcified left circumflex artery.A 3.00mm x 12mm nc emerge balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured, and it came off from the catheter.Additionally, a piece of the balloon remained in the vessel when the catheter was removed.The device stayed in place, and the physician was able to pass a wire beyond the fragment.The fragment was then stented against the vessel wall.There were no additional interventions performed.The procedure was completed, and no further issues were reported.
Event or Problem Description
It was reported that balloon detachment and balloon rupture occurred requiring treatment.The target lesion was located in the non-tortuous and moderately calcified left circumflex artery.A 3.00mm x 12mm nc emerge balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured, and it came off from the catheter.Additionally, a piece of the balloon remained in the vessel when the catheter was removed.The device stayed in place, and the physician was able to pass a wire beyond the fragment.The fragment was then stented against the vessel wall.There were no additional interventions performed.The procedure was completed, and no further issues were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: fg nc emerge mr, us 3.00mm x 12mm balloon catheter was returned for analysis.A visual and tactile inspection identified multiple kinks were noted along the hypotube shaft.A visual, tactile and microscopic inspection identified complete circumferential tear was noted 22.8cm from the port exchange with the distal section not returned.The inner lumen was detached 19.5cm from the port exchange.The break was inside the outer lumen.

• 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: 21973286
• Report Number: 2124215-2025-27478
• Device Sequence Number: 17958182
• Product Code: LOX
• UDI-Device Identifier: 08714729846390
• UDI-Public: (01)08714729846390(17)261106(10)35223113
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 07/11/2025

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: H7493926712300
• Device Catalogue Number: H7493926712300
• Device Lot Number: 0035223113
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown