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); Chest Pain (1776); Non specific EKG/ECG Changes (1817)

Event Date 01/25/2023

Event Type  Injury  

Event Description

It was reported that air embolism occurred.The opticross imaging catheter was advanced for ultrasound examination of the target lesion.During the run multiple air bubbles were visualized on screen and shortly after, the patient noted some mild chest discomfort.The physician stopped the imaging run and observed minor air embolism.The patient was noted to have minor st segment elevations on electrocardiography.The physician administered cardene and the patient then said his chest pain had resolved and the st segments notably returned to baseline.The procedure was completed without further issue and the patient made a full recovery.

Manufacturer Narrative

The device was returned for analysis.Visual inspection revealed no issues.It was observed that the catheter flushed normally when the imaging core was fully retracted and fully advanced.

Event Description

It was reported that air embolism occurred.The opticross imaging catheter was advanced for ultrasound examination of the target lesion.During the run multiple air bubbles were visualized on screen and shortly after, the patient noted some mild chest discomfort.The physician stopped the imaging run and observed minor air embolism.The patient was noted to have minor st segment elevations on electrocardiography.The physician administered cardene and the patient then said his chest pain had resolved and the st segments notably returned to baseline.The procedure was completed without further issue and the patient made a full recovery.

• Brand Name: OPTICROSS HD
• Type of Device: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16368451
• MDR Text Key: 309461860
• Report Number: 2124215-2023-06346
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2023
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0030366673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2022
• 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): Required Intervention
• Patient Sex: Male