Emerge?
Received Jul 30, 2026 · Event occurred Mar 24, 2026
Report 2124215-2026-41077 · MDR key 50091055
Device
Generic name
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Manufacturer
Boston Scientific CorporationModel number
H7493918912200Catalog number
H7493918912200
Lot number
0037743305
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
75 YR · Male
- Cardiac Arrest
- Low Blood Pressure/ Hypotension
Narrative
Description of Event or Problem
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.