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 Code	ST Segment Elevation (2059)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that st elevation occurred.An opticross imaging catheter was used to view the lesion.The st rates were fine before the ivus run.However, during the procedure, when the catheter was inserted they noticed that the patients st elevation increased.When the catheter was removed, the st rates went back to a normal level.The ivus was successfully completed.There was nothing wrong with the image and there was no intervention performed during the case.The procedure was completed with the original device used.No other patient complications were reported.
Event or Problem Description
It was reported that st elevation occurred.An opticross imaging catheter was used to view the lesion.The st rates were fine before the ivus run.However, during the procedure, when the catheter was inserted they noticed that the patients st elevation increased.When the catheter was removed, the st rates went back to a normal level.The ivus was successfully completed.There was nothing wrong with the image and there was no intervention performed during the case.The procedure was completed with the original device used.No other patient complications were reported.It was further reported that the 90% stenosed target lesion was located in the mildy tortuous and mildly calcified in left anterior descending (lad) artery.The patient's status was stable.

• 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: 8739455
• Report Number: 2134265-2019-07259
• Device Sequence Number: 1490076
• Product Code: OBJ
• UDI-Device Identifier: 08714729847878
• UDI-Public: 08714729847878
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2019

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: 02/01/2020
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0023281866
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 06/27/2019
• Supplement Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention