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

Model Number 8668

Device Problem Difficult to Flush (1251)

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

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

Date of event - used the first day of the month of the aware date since no exact date provided.

Event Description

It was reported that air embolism and st segment elevation occurred.The opticross hd imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure upon pullback, air bubbles were noted on the images resulting to air embolism and the patient began having st elevation.The catheter was removed and flushed.The procedure was completed successfully.No further patient complications were reported and the patient fully recovered.

Manufacturer Narrative

B3: date of event - used the first day of the month of the aware date since no exact date provided.

Event Description

It was reported that air embolism and st segment elevation occurred.The opticross hd imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure upon pullback, air bubbles were noted on the images resulting to air embolism and the patient began having st elevation.The catheter was removed and flushed.The procedure was completed successfully.No further patient complications were reported and the patient fully recovered.

• 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: 16500074
• MDR Text Key: 310852042
• Report Number: 2124215-2023-09859
• Device Sequence Number: 1
• Product Code: OBJ
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other