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

Model Number	H7493918912200
Medical Device Problem Codes	Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
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.Device evaluated by mfr: fg emerge mr, us 2.00mm x 12mm was returned for analysis.A visual and tactile inspection of the hypotube shaft identified no issues.A visual and tactile inspection of the outer and inner lumen and tactile examination of the entire extrusion identified a kink just proximal to the port exchange, and a microscopic examination did not identify any shaft hole or perforation along the length of the device.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.Bumper tip showed no signs of distal tip damage.A wire insertion test was performed on the device.The device could be loaded and tracked over a 0.014-inch guidewire without issue.As a shaft hole was reported, functional testing was performed.The device was attached to an encore inflation unit, and the balloon was inflated to the rated burst pressure (rbp) of 14 atmospheres (atm) successfully without issue.
Event or Problem Description
It was reported that shaft hole occurred.A 2.00mm x 12mm emerge balloon catheter was advanced for dilation.However, during the procedure, an unknown wire failed to exit through the receiving port as intended.Instead, the wire exited the catheter shaft just distal to the balloon.Subsequently, a hole was observed on the side of the shaft, proximal to the receiving port.The procedure was completed with a different device, and no patient complications were reported.
Event or Problem Description
It was reported that shaft hole occurred.A 2.00mm x 12mm emerge balloon catheter was advanced for dilation.However, during the procedure, an unknown wire failed to exit through the receiving port as intended.Instead, the wire exited the catheter shaft just distal to the balloon.Subsequently, a hole was observed on the side of the shaft, proximal to the receiving port.The procedure was completed with a different device, and 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.

• Brand Name: 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: 23578054
• Report Number: 2124215-2025-82067
• Device Sequence Number: 13137996
• Product Code: LOX
• UDI-Device Identifier: 08714729806080
• UDI-Public: (01)08714729806080(17)280315(10)36959334
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2025

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: H7493918912200
• Device Catalogue Number: H7493918912200
• Device Lot Number: 0036959334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2025
• 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