MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Emerge?; Catheters, Transluminal Coronary Angioplasty, Percutaneous

Model Number	H7493918912200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
Date of Event	03/24/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that patient death occurred.The patient underwent percutaneous coronary intervention (pci) to the diagonal artery and then returned four days later for a pci to the left anterior descending artery (lad).During the second procedure, the lad was successfully wired, the opticross imaging catheter was used for intravascular ultrasound (ivus) examination of the target lesion without issue.It was noted that the motor drive used during ivus appeared to make a strained noise when the catheter was running and being flushed at the same time.Ivus images were clear.A 2.00 x 12mm emerge catheter was used to balloon the artery.Following the second balloon inflation, the patient became hypotensive and lost blood pressure.Cpr was initiated immediately; however, the patient did not recover.The official cause of death was asystole.
Event or Problem Description
It was reported that patient death occurred.The patient underwent percutaneous coronary intervention (pci) to the diagonal artery and then returned four days later for a pci to the left anterior descending artery (lad).During the second procedure, the lad was successfully wired, the opticross imaging catheter was used for intravascular ultrasound (ivus) examination of the target lesion without issue.It was noted that the motor drive used during ivus appeared to make a strained noise when the catheter was running and being flushed at the same time.Ivus images were clear.A 2.00 x 12mm emerge catheter was used to balloon the artery.Following the second balloon inflation, the patient became hypotensive and lost blood pressure.Cpr was initiated immediately; however, the patient did not recover.The official cause of death was asystole.
Additional Manufacturer Narrative
G4: premarket / 510(k) # k113220, k163174.
Additional Manufacturer Narrative
G4: premarket / 510(k) # k113220, k163174.Investigation results: device analysis findings: the device was not returned for analysis; therefore, a technical analysis could not be performed.Device history record (dhr) review: review confirmed that the device met all material, assembly, and performance specifications prior to distribution.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.Investigation conclusion: this investigation has been assigned an investigation conclusion code of adverse event related to patient condition.It was reported that the patient had a procedure to treat the diagonal artery and then four days later a procedure with this emerge device to treat the left anterior descending (lad) artery.When this 2.00 x 12mm emerge, catheter was used to balloon the artery, following the second balloon inflation, the patient became hypotensive and lost blood pressure.Cardiopulmonary arrest was reported and cardiopulmonary resuscitation (cpr) was initiated immediately; however, the patient did not recover.The complaint did not report any device malfunction with the device which could potentially have contributed to the complaint event.The official cause of death was asystole.Asystole occurs when the hearts electrical system fails entirely, which causes the heart to stop pumping.

• 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 ; +1(612)875-7234
• MDR Report Key: 50091055
• Report Number: 2124215-2026-41077
• Device Sequence Number: 18733932
• Product Code: LOX
• UDI-Device Identifier: 08714729806080
• UDI-Public: (01)08714729806080(17)280621(10)37743305
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: H7493918912200
• Device Catalogue Number: H7493918912200
• Device Lot Number: 0037743305
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 10/20/2025
• 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
• Patient Age: 75 YR
• Patient Sex: Male