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

Model Number	H7493926712200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is an estimated date based on the aware date as the exact event date was not reported.
Event or Problem Description
It was reported that balloon rupture and dissection occurred.The patient presented with chest pain and anterior st-elevation.Vascular access was obtained via the right radial artery.Angiography revealed severely calcific coronary disease with a 99% mid left anterior descending artery (lad) stenosis with timi 2 flow and a 99% proximal large diagonal stenosis.A 2.50mm x 12mm emerge balloon was unable to dilate the lad at 20 atmospheres (atm) because of the heavy calcification and the balloon ruptured.A cutting balloon was then selected but would not cross the lesion.A 2.00mm x 12mm nc emerge balloon was selected to dilate the diagonal and that balloon ruptured at 12 atm.A local dissection in the diagonal was also noted and a non-boston scientific (bsc) balloon was selected to successfully dilate the lesions at 12-14 atm.The lad was then stented with a 2.25 mm x 20 mm synergy drug eluting stent at 18 atm and the diagonal stented with a 2.25 mm x 12 mm synergy stent at 16 atm.A non-bsc guide extension catheter was used to assist in the balloon and stent placements and the end result was excellent.This was a bifurcation or v stent and the lad stent had to be redilated after stenting the diagonal.No patient complications were reported.

• 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; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21472450
• Report Number: 2124215-2025-09452
• Device Sequence Number: 14300561
• Product Code: LOX
• UDI-Device Identifier: 08714729846352
• UDI-Public: 08714729846352
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2025

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: H7493926712200
• Device Catalogue Number: H7493926712200
• 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: 02/04/2025
• Initial Report FDA Received Date: 02/26/2025
• 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: Other
• Patient Sex: Unknown