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

Model Number	H7493926715270
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft break occurred.The patient was undergoing percutaneous coronary intervention.The 85% stenosed, 2.9mmx28mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.75mm x 15mm nc emerge balloon catheter was advanced for dilatation.During insertion, the device delivery shaft was fractured, and the balloon tube had a kink mark.The balloon was withdrawn from the body and a new device was used to complete the procedure.The patient condition following the procedure was stable.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Additional Manufacturer Narrative
Device evaluated by mfr.: fg nc emerge mr us, 2.75mm x 15mm was returned for analysis.A visual and tactile examination identified a kink in the mid shaft at 2cm from the guidewire exchange port.No issues identified with hypotube.Microscopic examination of balloon material found no issues.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Bumper tip showed no signs of distal tip damage.No other device issues were identified during returned product analysis.E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that shaft break occurred.The patient was undergoing percutaneous coronary intervention.The 85% stenosed, 2.9mmx28mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 2.75mm x 15mm nc emerge balloon catheter was advanced for dilatation.During insertion, the device delivery shaft was fractured, and the balloon tube had a kink mark.The balloon was withdrawn from the body and a new device was used to complete the procedure.The patient condition following the procedure was stable.

• 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: 21873646
• Report Number: 2124215-2025-25009
• Device Sequence Number: 8742327
• Product Code: LOX
• UDI-Device Identifier: 08714729846512
• UDI-Public: (01)08714729846512(17)250406(10)31382884
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: 04/06/2025
• Device Model Number: H7493926715270
• Device Catalogue Number: H7493926715270
• Device Lot Number: 0031382884
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2023
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 79 KG