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

Model Number	8655
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Ventricular Fibrillation (2130); Embolism/Embolus (4438)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an air embolism occurred.The target lesion was located in the left main.The opticross imaging catheter was advanced for ultrasound examination of the target lesion.At some point it was noticed that an air embolism went down the left anterior descending artery.The patient began experiencing chest pain and was having difficulty breathing.The patient also experienced ventricular fibrillation.The patient was put on 100% oxygen and a dopamine drip.A non-boston scientific aspiration catheter was used to remove the air embolism and the patient made a full recovery.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed no issued; the device appears to be in good condition.No damages or failures were noted on the catheter code pcba board assembly.It was observed that the catheter flushed normally when the imaging core was fully retracted and fully advanced.Impedance test was performed which showed an electrical short at the distal wave form.Microscopic inspection revealed pitting and degradation of the transducer housing consistent with saline damage which occurs post-use of the device and is not related to the original device failure.There was no damage observed on the distal tip or guidewire exit port assembly.The catheter was properly recognized by the imaging system when plugged into the motor drive unit and no connection issues or errors were detected during its testing.It was observed that the catheter flushed normally when the imaging core was fully retracted and fully advanced.The complaint device was sent for x-ray analysis to further characterize the electrical failure.Based on the x-ray analysis, no discernible defect could be seen.
Event or Problem Description
It was reported that an air embolism occurred.The target lesion was located in the left main.The opticross imaging catheter was advanced for ultrasound examination of the target lesion.At some point it was noticed that an air embolism went down the left anterior descending artery.The patient began experiencing chest pain and was having difficulty breathing.The patient also experienced ventricular fibrillation.The patient was put on 100% oxygen and a dopamine drip.A non-boston scientific aspiration catheter was used to remove the air embolism and the patient made a full recovery.

• Brand Name: OPTICROSS
• Common Device Name: 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13261075
• Report Number: 2134265-2022-00288
• Device Sequence Number: 1546702
• Product Code: OBJ
• UDI-Device Identifier: 08714729847878
• UDI-Public: 08714729847878
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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: 11/21/2022
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0028426372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male