MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS? HD; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	H74939352040
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Codes	Air Embolism (1697); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Reduced Blood Flow (4598)
Date of Event	04/24/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
G4: premarket / 510(k) # k173284, k213593.
Event or Problem Description
It was reported that a patient death occurred.The stenosed target lesion was located in the distal left main coronary artery.The opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) of the target lesion.As the physician attempted to pass the ivus catheter across the lesion, imaging was activated and an artifact was observed on the screen.The technician was asked whether flushing was occurring, and they confirmed that it was.The technician was then instructed to stop flushing, and the physician and technician decided to remove and re-prep the catheter.The physician noted elevated st-segments, and contrast injection revealed a slow-flow phenomenon.A decision was made to aspirate the left anterior descending artery (lad).Aspiration was performed, which restored some flow to the proximal lad.However, the patients condition worsened, and they went into cardiac arrest with pulseless electrical activity (pea).Cardiopulmonary resuscitation (cpr) was initiated, and a percutaneous left ventricular assist device (lvad) was inserted.Coronary angiography performed after impella placement showed normal coronary flow.Despite efforts, the patient died following a prolonged pea arrest.Post-procedure inspection of the catheter revealed air in the clear lumen.It was noted that the supplied extension tubing had not been used; instead, tubing from a different manufacturer had been connected to the boston scientific stopcock and syringes.The physician believed that improper catheter preparation led to an air embolism.The procedure was not completed due to this event.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed no issues, and the device appeared to be in good condition.The flushing accessories were not returned for analysis.Functional inspection of the motor drive unit (mdu) and ilab system showed that the catheter flushed normally when the telescope was fully retracted and fully advanced.An impedance test showed no electrical issues.A clear square image appeared on the ilab system during image characterization testing.During the flush test, no air bubbles remained inside the catheter after flushing, and no signs of leakage were observed.G4: premarket / 510(k) # k173284, k213593.H6 impact codes: corrected.
Event or Problem Description
It was reported that a patient death occurred.The stenosed target lesion was located in the distal left main coronary artery.The opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) of the target lesion.As the physician attempted to pass the ivus catheter across the lesion, imaging was activated and an artifact was observed on the screen.The technician was asked whether flushing was occurring, and they confirmed that it was.The technician was then instructed to stop flushing, and the physician and technician decided to remove and re-prep the catheter.The physician noted elevated st-segments, and contrast injection revealed a slow-flow phenomenon.A decision was made to aspirate the left anterior descending artery (lad).Aspiration was performed, which restored some flow to the proximal lad.However, the patients condition worsened, and they went into cardiac arrest with pulseless electrical activity (pea).Cardiopulmonary resuscitation (cpr) was initiated, and a percutaneous left ventricular assist device (lvad) was inserted.Coronary angiography performed after impella placement showed normal coronary flow.Despite efforts, the patient died following a prolonged pea arrest.Post-procedure inspection of the catheter revealed air in the clear lumen.It was noted that the supplied extension tubing had not been used; instead, tubing from a different manufacturer had been connected to the boston scientific stopcock and syringes.The physician believed that improper catheter preparation led to an air embolism.The procedure was not completed due to this event.

• Brand Name: OPTICROSS? HD
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 22074303
• Report Number: 2124215-2025-31098
• Device Sequence Number: 9394200
• Product Code: OBJ
• UDI-Device Identifier: 08714729960737
• UDI-Public: (01)08714729960737(17)250824(10)34705159
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173284
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/24/2025
• Device Model Number: H74939352040
• Device Catalogue Number: H74939352040
• Device Lot Number: 0034705159
• 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: 04/24/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Male