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

Model Number	8655
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Codes	Air Embolism (1697); Obstruction/Occlusion (2422)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that air embolism and no flow occurred.During a procedure involving an opticross us imaging catheter, the technician was flushing the device and air was injected into the vessel.The patient was unstable for a few minutes with no flow.The vessel was reopened and the patient was fine.

• Brand Name: OPTICROSS
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12553729
• Report Number: 2134265-2021-12292
• Device Sequence Number: 983181
• Product Code: OBJ
• UDI-Device Identifier: 08714729847878
• UDI-Public: 08714729847878
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2021

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: 08/11/2022
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0027822558
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 09/30/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention