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

Model Number	H7493926708600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: the event date was approximated to 03/01/2025 since the only given information was only the month and year.
Event or Problem Description
It was reported via medsun # 3902560000-2025-8066 that shaft break occurred requiring additional intervention.During a cardiac catheterization procedure, a 3.5 x 38mm non-boston scientific (bsc) stent was successfully deployed from the left main (lm) to mid left circumflex artery.The proximal optimization technique was the performed of the lm with a 6.00mm x 8mm nc emerge balloon catheter.Upon removal of the device, the balloon shaft broke and remained in the lm.To retrieve the broken balloon safely, a non-bsc wire was advanced parallel to another non-bsc wire, and a 2.5 x 15mm non-bsc balloon catheter was partially deployed within the guide to anchor the deflated 6.0mm emerge balloon fragment.The guide, wires and balloons were then completely removed from the body under fluoroscopy.The emerge balloon was inspected and was removed from the body in its entirety.The procedure was completed with another device.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; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22063492
• Report Number: 2124215-2025-28416
• Device Sequence Number: 12848915
• Product Code: LOX
• UDI-Device Identifier: 08714729846345
• UDI-Public: (01)08714729846345(17)250827(10)32310834
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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: 08/27/2025
• Device Model Number: H7493926708600
• Device Catalogue Number: H7493926708600
• Device Lot Number: 0032310834
• 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: 04/24/2025
• Initial Report FDA Received Date: 05/21/2025
• Date Device Manufactured: 08/28/2023
• 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 Age: 62 YR
• Patient Sex: Male