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

Model Number	H7493918908120
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket / 510(k) #: k130391, k163174.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with a coronary artery disease and underwent percutaneous coronary intervention.The target lesion was located in the right coronary artery.A 1.20mm x 8mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the balloon broke off in the coronary artery.Another 1.20mm x 15mm emerge balloon catheter was advanced; but the balloon also broke off in the coronary artery.The devices were simply removed from the patient in one piece, and an alternate device was then used to complete the procedure.There were no patient complications, and the patient was expected to fully recover.
Additional Manufacturer Narrative
G4: premarket / 510(k) #: k130391, k163174.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with a coronary artery disease and underwent percutaneous coronary intervention.The target lesion was located in the right coronary artery.A 1.20mm x 8mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the balloon broke off in the coronary artery.Another 1.20mm x 15mm emerge balloon catheter was advanced; but the balloon also broke off in the coronary artery.The devices were simply removed from the patient in one piece, and an alternate device was then used to complete the procedure.There were no patient complications, and the patient was expected to fully recover.It was further reported that the break occurred while attempting to cross the lesion.
Additional Manufacturer Narrative
G4: premarket/510(k) #: k130391, k163174.Investigation results: device analysis findings: fg emerge mr, us 1.20 mm x 8 mm balloon catheter was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile examination identified no issues along the hypotube shaft.Visual and tactile examination identified multiple kinks along the midshaft.In addition, a break was noted at the port exchange, 23.3 cm from the distal bumper tip.Balloon cones were reviewed, and no issues were noted.Balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A microscopic examination of the bumper tip showed no signs of distal tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.No other device issues were identified during returned product analysis.Device history record review: it was confirmed that this device met manufacturing specification prior to distribution and there are no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review was performed, and it confirmed that the event was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: this investigation is assigned a conclusion code of cause not established.This code was selected as the most probable complaint cause based on the information available.It was reported that shaft break occurred.Device analysis confirmed the reported event however based on the condition of the returned device and the fact that no procedural or patient details were provided a clear conclusion to the break cannot be determined.
Event or Problem Description
It was reported that shaft break occurred.The patient presented with a coronary artery disease and underwent percutaneous coronary intervention.The target lesion was located in the right coronary artery.A 1.20 mm x 8 mm emerge balloon catheter was advanced for dilatation.However, during the procedure, the balloon broke off in the coronary artery.Another 1.20 mm x 15 mm emerge balloon catheter was advanced; but the balloon also broke off in the coronary artery.The devices were simply removed from the patient in one piece, and an alternate device was then used to complete the procedure.There were no patient complications, and the patient was expected to fully recover.It was further reported that the break occurred while attempting to cross the lesion.

• 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: 24314530
• Report Number: 2124215-2026-07703
• Device Sequence Number: 14668343
• Product Code: LOX
• UDI-Device Identifier: 08714729806486
• UDI-Public: (01)08714729806486(17)280101(10)36418373
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2026

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: H7493918908120
• Device Catalogue Number: H7493918908120
• Device Lot Number: 0036418373
• 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: 01/20/2026
• Supplement Date Received by Manufacturer: 03/05/2026; 04/24/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/30/2026; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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