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

Model Number	H7493918912250
Medical Device Problem Codes	Nonstandard Device (1420); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket/510(k) #: k113220, k163174.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located within a heavily calcified segment.A 2.50 mm x 12 mm emerge balloon catheter was advanced for dilation.However, during initial inflation, the balloon ruptured.The device was removed with no fragments left inside the patient.The procedure was completed with a different device, and no patient complications were reported.
Additional Manufacturer Narrative
G4.Premarket / 510(k) #: k113220, k163174 device evaluated by mfr: fg emerge mr, us 2.50mm x 12mm was returned for analysis.A visual and tactile examination of the hypotube found multiple kinks along the shaft.A visual and tactile examination of the outer lumen and mid-shaft section found no issues, and a microscopic examination identified that the inner lumen was bunched and stretched at 19cm from the port exchange.Further stretching was identified along the inner lumen, resulting in the proximal section of the balloon being pulled proximally away from the proximal markerband.A visual, tactile and microscopic examination of the balloon material identified a complete circumferential balloon tear 8mm from proximal balloon sleeve.The distal section of the balloon tear was pulled out over the tip of the device.A visual examination of the tip showed no signs of damage.A microscopic examination of the proximal and distal markerbands identified no damage.An examination on the inner/wire lumen identified that the inner was stretched and as a result a 0.014-inch wire could not load through the inner/wire lumen.
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located within a heavily calcified segment.A 2.50mm x 12mm emerge balloon catheter was advanced for dilation.However, during initial inflation, the balloon ruptured.The device was removed with no fragments left inside the patient.The procedure was completed with a different device, and no patient complications were reported.

• 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: 23404550
• Report Number: 2124215-2025-77256
• Device Sequence Number: 14687458
• Product Code: LOX
• UDI-Device Identifier: 08714729806103
• UDI-Public: (01)08714729806103(17)280316(10)36972362
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 12/19/2025

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: H7493918912250
• Device Catalogue Number: H7493918912250
• Device Lot Number: 0036972362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• 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