MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	8864
Medical Device Problem Codes	Failure to Power Up (1476); Computer Operating System Problem (2898)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cancelled procedure occurred.A polaris mobile 120v was used as the console to view the target lesion.It was noted that the patient was sedated.During percutaneous coronary intervention, the polaris screen displayed startup failure and acquisition pc not powered on.Therefore, the procedure was cancelled.No patient complications were reported.

• Brand Name: ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10063088
• Report Number: 2134265-2020-06484
• Device Sequence Number: 2680470
• Product Code: DQK
• UDI-Device Identifier: 08714729946106
• UDI-Public: 08714729946106
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K151613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8864
• Device Catalogue Number: 8864
• Device Lot Number: 0000200474
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 05/15/2020
• Patient Sequence Number: 1