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

Model Number	H7493926712300
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon detachment occurred requiring intervention.The patient presented with coronary artery disease and was undergoing percutaneous coronary intervention.The target lesion was more than 70% stenosed and was located in non-tortuous vessel.A 3.00mm x 12mm nc emerge balloon catheter was advanced for post dilatation.After removal of the device, it was observed that the balloon fractured and part of it was in the ostial right coronary.A guidewire was used to snare the broken piece of the balloon into the guide catheter, and everything was removed together.The procedure was completed using an alternate method.No patient complications were reported.
Event or Problem Description
It was reported that balloon detachment occurred requiring intervention.The patient presented with coronary artery disease and was undergoing percutaneous coronary intervention.The target lesion was more than 70% stenosed and was located in non-tortuous vessel.A 3.00mm x 12mm nc emerge balloon catheter was advanced for post dilatation.After removal of the device, it was observed that the balloon fractured and part of it was in the ostial right coronary.A guidewire was used to snare the broken piece of the balloon into the guide catheter, and everything was removed together.The procedure was completed using an alternate method.No patient complications were reported.It was further reported that there were no issues noted with the packaging of the device.Additionally, the balloon was inflated, and.014 guidewire was used to snare the broken piece into a non-boston scientific guide catheter.
Additional Manufacturer Narrative
Device evaluated by mfr: fg nc emerge mr, us 3.00mm x 12mm balloon delivery system was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination of the hypotube shaft identified multiple hypotube kinks.A visual and tactile examination of the outer and inner lumen identified a 6cm portion of the inner lumen separated from the balloon and delivery system with evidence of stretching.Visual examination of the balloon identified a complete circumferential tear with a portion of the balloon detached.The detached portion was returned for analysis, and a piece of unidentified material was stuck in the balloon.Microscopic examination of the inner lumen noted that the inner lumen was detached at 19.1cm from the port exchange.The bumper tip was not returned for product analysis.
Event or Problem Description
It was reported that balloon detachment occurred requiring intervention.The patient presented with coronary artery disease and was undergoing percutaneous coronary intervention.The target lesion was more than 70% stenosed and was located in non-tortuous vessel.A 3.00mm x 12mm nc emerge balloon catheter was advanced for post dilatation.After removal of the device, it was observed that the balloon fractured and part of it was in the ostial right coronary.A guidewire was used to snare the broken piece of the balloon into the guide catheter, and everything was removed together.The procedure was completed using an alternate method.No patient complications were reported.It was further reported that there were no issues noted with the packaging of the device.Additionally, the balloon was inflated, and.014 guidewire was used to snare the broken piece into a non-boston scientific guide catheter.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 21349859
• Report Number: 2124215-2025-05354
• Device Sequence Number: 15417303
• Product Code: LOX
• UDI-Device Identifier: 08714729846390
• UDI-Public: (01)08714729846390(17)250422(10)31481298
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• 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: 04/22/2025
• Device Model Number: H7493926712300
• Device Catalogue Number: H7493926712300
• Device Lot Number: 0031481298
• 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: 01/20/2025
• Supplement Date Received by Manufacturer: 02/06/2025; 04/09/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/03/2025; 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown