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

Model Number	H7493926715300
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
Same case as tw# (b)(4).It was reported that balloon rupture occurred.A >90% stenosed target lesion was located in the coronary artery.A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilation.However, during inflation at nominal pressure, the balloon ruptured.The device was removed and replaced with another 3.00mm x 15mm nc emerge balloon catheter which also ruptured at nominal pressure.The device was also removed, and the procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
Same case as tw# (b)(4).It was reported that balloon rupture occurred.A >90% stenosed target lesion was located in the coronary artery.A 3.00mm x 15mm nc emerge balloon catheter was advanced for dilation.However, during inflation at nominal pressure, the balloon ruptured.The device was removed and replaced with another 3.00mm x 15mm nc emerge balloon catheter which also ruptured at nominal pressure.The device was also removed, and the procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: fg nc emerge mr, us 3.00mm x 15mm was returned for analysis.A visual and tactile examination identified no issues with the hypotube shaft.A visual and tactile examination identified no issues identified with the outer / mid-shaft sections or the inner lumen of the device.A microscopic examination of the inner wire lumen identified a pinhole perforation in the inner/outer wire lumen at 4.8cm from the distal tip.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.A functional analysis was performed.The encore device was verified before use by using the druck gauge.An attempt was made to inflate the balloon to its rated burst pressure (rbp) of 20 atmospheres (atm) as per instructions for use (ifu).However, due to liquid leakage through the distal tip of the device, it was unable to reach rbp.Due to the pinhole perforation in the inner wire lumen, it was not possible for the balloon to maintain pressure as liquid leaked out through the distal tip end of the device.

• 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: 22122907
• Report Number: 2124215-2025-35778
• Device Sequence Number: 7157135
• Product Code: LOX
• UDI-Device Identifier: 08714729846529
• UDI-Public: (01)08714729846529(17)270317(10)36080159
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 07/09/2025

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 Model Number: H7493926715300
• Device Catalogue Number: H7493926715300
• Device Lot Number: 0036080159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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 Sex: Unknown