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

Model Number	8668
Medical Device Problem Codes	Poor Quality Image (1408); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient complications occurred.The opticross hd imaging catheter was advanced for intravascular ultrasound examination of the target lesion.During procedure, the physician was concerned that there was a possible fracture in the monorail portion that could have caused a possible air embolus and patient had some st elevation.The catheter was removed and flushed to ensure the tip was still intact.The procedure was completed with another of the same device.There were no patient injuries reported and the patient did very well.
Event or Problem Description
It was reported that patient complications occurred.The opticross hd imaging catheter was advanced for intravascular ultrasound examination of the target lesion.During procedure, the physician was concerned that there was a possible fracture in the monorail portion that could have caused a possible air embolus and patient had some st elevation.The catheter was removed and flushed to ensure the tip was still intact.The procedure was completed with another of the same device.There were no patient injuries reported and the patient did very well.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection that no issues were found, and the device appears to be in good condition.The imaging core impedance test shows a complete circuit curve, and the transducer level impedance test shows a good rh peak of 40 ohms.Also, a good square image appeared in the ilab system during image characterization testing.The media attached to the parent record does not show any evidence of the reported issue.Based on the evidence, the as reported code of sheath detachment of device or device component, image poor, catheter kinked cannot be confirmed.

• Brand Name: OPTICROSS HD
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19533625
• Report Number: 2124215-2024-35224
• Device Sequence Number: 7575006
• Product Code: OBJ
• UDI-Device Identifier: 08714729960737
• UDI-Public: 08714729960737
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2024
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0033019501
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Male
• Patient Race: White