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

Model Number	8655
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E3 date of event: 10/01/2024 used as approximate date as actual event date is unknown.
Event or Problem Description
It was reported that an st elevation occurred.The opticross imaging catheter was selected for ultrasound examination of the target lesion.During an ivus catheter pullback, imaging was lost as they neared the proximal vessel.Despite attempts to flush the catheter, the image was not restored.The patient simultaneously developed significant st elevation on the ecg, prompting them to remove the catheter.After removal, the patient was stabilized and the st elevation gradually subsided.The introduction of air from the device or procedure caused or contributed to the patient's complication.The procedure was successfully completed using original method or device.The patient was fully recovered.
Event or Problem Description
It was reported that an st elevation occurred.The opticross imaging catheter was selected for ultrasound examination of the target lesion.During an ivus catheter pullback, imaging was lost as they neared the proximal vessel.Despite attempts to flush the catheter, the image was not restored.The patient simultaneously developed significant st elevation on the ecg, prompting them to remove the catheter.After removal, the patient was stabilized and the st elevation gradually subsided.The introduction of air from the device or procedure caused or contributed to the patients complication.The procedure was successfully completed using original method or device.The patient was fully recovered.
Additional Manufacturer Narrative
E3 date of event: 10/01/2024 used as approximate date as actual event date is unknown.Returned device consisted of the opticross imaging catheter a visual inspection revealed no damages or defects.Impedance and image testing was all good, so the reported complaint could not be confirmed.

• Brand Name: OPTICROSS
• 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: 20695659
• Report Number: 2124215-2024-71985
• Device Sequence Number: 15091986
• Product Code: OBJ
• UDI-Device Identifier: 08714729841531
• UDI-Public: 08714729841531
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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: 07/29/2025
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0034528784
• 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: 10/28/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Other
• Patient Sex: Unknown