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

Model Number	8655
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(6).
Event or Problem Description
It was reported that catheter break occurred.The target lesion was located in the circumflex artery.An opticross imaging catheter was selected for use.During procedure, when they were going in with the device inside the patient's body, it was noted that the device bent and broke.The procedure was completed with a non bsc device.No harm to the patient.No patient complications were reported.
Additional Manufacturer Narrative
Age at time of event: 18 years or older.Initial reporter address 1 (b)(6).
Event or Problem Description
It was reported that catheter break occurred.The target lesion was located in the circumflex artery.An opticross imaging catheter was selected for use.During procedure, when they were going in with the device inside the patient's body, it was noted that the device bent and broke.The procedure was completed with a non bsc device.No harm to the patient.No patient complications were reported.It was further reported that about 95% stenosed target lesion was located in the 90 degree torturous vessels with a mixed plaque and calcium circumflex artery.The patient 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: 8541428
• Report Number: 2134265-2019-04238
• Device Sequence Number: 13889392
• Product Code: OBJ
• UDI-Device Identifier: 08714729847878
• UDI-Public: 08714729847878
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2019
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0023101476
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/19/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR