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

Model Number	H7493918930250
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Obstruction/Occlusion (2422); Foreign Body In Patient (2687); Asystole (4442); Reduced Blood Flow (4598)
Date of Event	08/29/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient died.The patient underwent a percutaneous coronary intervention (pci) procedure targeting both the left anterior descending (lad) and the right coronary artery (rca).During treatment of a long, moderately calcified and mildly tortuous lesion in the rca, a 2.50 mm x 30 mm emerge balloon catheter was advanced for dilatation.At the beginning of the third inflation, the balloon ruptured at a pressure of less than 14 atm.Following the rupture, no blood flow in the rca and the patient experienced a brief asystolic episode.The physician attempted to remove the device, however, only the catheter shaft was retrieved.The full 30 mm balloon material remained inside the patient and was not visible on angiography.The physician proceeded to place stent in the rca to restore blood flow, which was successfully re-established.The patient was stable post-procedure and was discharged the same day.Two days post-discharge, the patient returned to the hospital in a worsened condition.A diagnostic coronary angiography revealed a complete occlusion of the rca, which could not be re-opened.The patient subsequently passed away, with cardiac failure listed as the official cause of death.
Additional Manufacturer Narrative
G4: premarket / 510(k): k163174.
Additional Manufacturer Narrative
E1: initial reporter email updated.G4: premarket/510(k): k163174.
Event or Problem Description
It was reported that a patient died.The patient underwent a percutaneous coronary intervention (pci) procedure targeting both the left anterior descending (lad) and the right coronary artery (rca).During treatment of a long, moderately calcified and mildly tortuous lesion in the rca, a 2.50 mm x 30 mm emerge balloon catheter was advanced for dilatation.At the beginning of the third inflation, the balloon ruptured at a pressure of less than 14 atm.Following the rupture, no blood flow in the rca and the patient experienced a brief asystolic episode.The physician attempted to remove the device, however, only the catheter shaft was retrieved.The full 30 mm balloon material remained inside the patient and was not visible on angiography.The physician proceeded to place stent in the rca to restore blood flow, which was successfully re-established.The patient was stable post-procedure and was discharged the same day.Two days post-discharge, the patient returned to the hospital in a worsened condition.A diagnostic coronary angiography revealed a complete occlusion of the rca, which could not be re-opened.The patient subsequently passed away, with cardiac failure listed as the official cause of death.It was further reported that the physician attempted retrieval using a lasso, a standard technique for foreign body extraction, though the effort was unsuccessful.

• 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; 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: 23181899
• Report Number: 2124215-2025-66332
• Device Sequence Number: 9182412
• Product Code: LOX
• UDI-Device Identifier: 08714729806417
• UDI-Public: (01)08714729806417(17)271031(10)35960402
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H7493918930250
• Device Catalogue Number: H7493918930250
• Device Lot Number: 0035960402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 10/31/2025
• Date Device Manufactured: 02/28/2025
• 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
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female