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

Model Number	H7493926712250
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty and shaft break occurred.A 2.50 mm x 12 mm nc emerge balloon catheter was advanced and used for simultaneous ballooning (kissing balloon technique) from the ramus and left circumflex into the left main artery.However, upon withdrawal, the balloon encountered lot of resistance, and it broke.The balloon was removed and the procedure was completed with a new balloon.No patient complications were reported.
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.
Additional Manufacturer Narrative
Device evaluated by mfr.: fg nc emerge mr, us 2.50mm x 12mm was returned for analysis.A visual and tactile examination confirm that a break existed at port exchange.No issues identified with the hypotube shaft.A detailed microscopic examination identified that the polymer extrusion was stretched and accordioned.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.Tip showed no signs of tip damage.No other device issues were identified during returned product analysis.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
It was reported that removal difficulty and shaft break occurred.A 2.50 mm x 12 mm nc emerge balloon catheter was advanced and used for simultaneous ballooning (kissing balloon technique) from the ramus and left circumflex into the left main artery.However, upon withdrawal, the balloon encountered lot of resistance, and it broke.The balloon was removed and the procedure was completed with a new balloon.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; 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: 21887826
• Report Number: 2124215-2025-23681
• Device Sequence Number: 19715421
• Product Code: LOX
• UDI-Device Identifier: 08714729846376
• UDI-Public: (01)08714729846376(17)261210(10)35457458
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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: H7493926712250
• Device Catalogue Number: H7493926712250
• Device Lot Number: 0035457458
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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 Sex: Unknown