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

Model Number	H7493918915120
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
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.
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) #: k163174.Investigation results: device analysis findings: emerge mr, us 1.20mm x 15mm, catheter was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.A visual and tactile inspection identified multiple kinks along the hypotube shaft.Multiple kinks were identified along the midshaft with stretching and a break noted in the shaft polymer extrusion, 2.5cm from the port exchange.The distal section from that break was not returned.A microscopic examination of the midshaft was stretched and a break was noted in the shaft polymer extrusion, 2.5cm from the port exchange.The distal section from that break was not returned.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there 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 and is recorded accordingly in the product record review table.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.A previous device had broken off in the coronary artery where this 1.20x15mm emerge device was advanced and had also broken.Device analysis confirmed the reported event however due to the condition of the returned device a clear conclusion to the break cannot be determined.The break was identified in the shaft polymer extrusion which was stretched and the distal sectioned not returned.
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.

• 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: 24314520
• Report Number: 2124215-2026-07711
• Device Sequence Number: 4862830
• Product Code: LOX
• UDI-Device Identifier: 08714729806172
• UDI-Public: (01)08714729806172(17)280101(10)36418374
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K130391
• 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): 04/16/2026

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: H7493918915120
• Device Catalogue Number: H7493918915120
• Device Lot Number: 0036418374
• 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; 03/31/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 03/30/2026; 04/16/2026
• 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