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

Model Number 8668

Device Problems Difficult to Flush (1251); Poor Quality Image (1408)

Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817)

Event Date 03/24/2023

Event Type  Injury  

Event Description

It was reported that air embolism, st elevation and no flow occurred.The target lesion was located in the left anterior descending artery.The opticross hd imaging catheter was advanced for ultrasound examination of the target lesion.Image fallout occurred with injection using a 3cc syringe.Air embolism followed with st elevation causing no flow in the artery.Nicardipine was given to treat the embolism.The procedure was completed successfully and the patient fully recovered.

Event Description

It was reported that air embolism, st elevation and no flow occurred.The target lesion was located in the left anterior descending artery.The opticross hd imaging catheter was advanced for ultrasound examination of the target lesion.Image fallout occurred with injection using a 3cc syringe.Air embolism followed with st elevation causing no flow in the artery.Nicardipine was given to treat the embolism.The procedure was completed successfully and the patient fully recovered.It was further reported via medwatch (b)(4) that the image became dark indicating air bubbles in the system.Liquid was purged to get the image back and shortly after the purge, the patient developed st elevation.The patient did not experience any pain.

• Brand Name: OPTICROSS HD
• Type of Device: 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16715929
• MDR Text Key: 313057898
• Report Number: 2124215-2023-16896
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 08714729960737
• UDI-Public: 08714729960737
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0030958587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2023
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention