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

Model Number	H7493926712250
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the right coronary artery.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The device was removed successfully from the patient, and the procedure was completed with a non-boston scientific device.No patient complications were reported.
Additional Manufacturer Narrative
Updated: a2: age at time of event, unit of measure - age.A3: sex.A4: weight, unit of measure - weight.A5: ethnicity.A6: race.B5.Describe event or problem.G2: report source.
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the right coronary artery.A 2.50mm x 12mm nc emerge balloon catheter was advanced for dilation.However, during inflation, the balloon ruptured.The device was removed successfully from the patient, and the procedure was completed with a non-boston scientific device.No patient complications were reported.It was further reported via medwatch report mw5170503 that a post-angiogram was performed, which showed no damage to the vessels.

• 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: 22053537
• Report Number: 2124215-2025-32347
• Device Sequence Number: 20131728
• Product Code: LOX
• UDI-Device Identifier: 08714729846376
• UDI-Public: (01)08714729846376(17)260912(10)34833887
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2025

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: 09/12/2026
• Device Model Number: H7493926712250
• Device Catalogue Number: H7493926712250
• Device Lot Number: 0034833887
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/19/2025
• Date Device Manufactured: 09/12/2024
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White