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

Model Number	H7493926712500
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438)
Date of Event	04/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a device issue occurred resulting in embolism.The target lesion was located in the severely calcified renal artery.A 5.00mm x 12mm nc emerge balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured, and part of the balloon was missing from the end of the catheter upon removal.Additionally, a fragment of the balloon sheared off and embolized into the patient's renal arteries.Details on further action for the detached portion were not provided.
Additional Manufacturer Narrative
It was reported that the balloon ruptured after inflation in the lesion and a part of the balloon was missing from the end of the catheter.The event stated that the lesion was in the renal artery.The nc emerge device is not designed for use in this anatomical location.The reported event is likely due to off label use.Good faith effort attempts were made to try and retrieve additional details regarding the reported balloon rupture, patient complications and actions taken regarding detached portion of the device, but further information was unable to be obtained.

• 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: 21951438
• Report Number: 2124215-2025-27477
• Device Sequence Number: 18351863
• Product Code: LOX
• UDI-Device Identifier: 08714729846451
• UDI-Public: (01)08714729846451(17)260523(10)34091503
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Report Date (Section B): 05/02/2025

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 Expiration Date: 05/23/2026
• Device Model Number: H7493926712500
• Device Catalogue Number: H7493926712500
• Device Lot Number: 0034091503
• 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: 04/10/2025
• Initial Report FDA Received Date: 05/02/2025
• Date Device Manufactured: 05/23/2024
• 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: Other
• Patient Sex: Unknown