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 02/21/2023

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that air embolism and st segment elevation occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.An opticross hd imaging catheter was selected for ultrasound examination of the target lesion.During the preparation, the device was difficult to flush but was able to flush eventually.The catheter was inserted and produced a good image.However, the physician considered it had air contamination, so it was removed and was flushed again outside the patient's body.The catheter was inserted again, however, during pullback, it had air contamination again and was flushed again while inside the patient.After that, st segment elevation occurred.No action was taken, and issue was resolved.The procedure was completed with this device and no further patient complications were reported.

• 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 DE COSTA RICA S.R.L.; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16534859
• MDR Text Key: 311201457
• Report Number: 2124215-2023-10967
• Device Sequence Number: 1
• Product Code: OBJ
• UDI-Device Identifier: 08714729960737
• UDI-Public: 08714729960737
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2023
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0029994579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other