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

Model Number	8864
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Complaint, Ill-Defined (2331)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cancelled procedure occurred.A polaris mmg system was selected for use.During procedure, it was noted that the unit is experiencing image issues.The procedure was not completed due to this event.No patient complications were reported.
Additional Manufacturer Narrative
The acquisition processor was returned with software that was not compatible with the current system; therefore, functional testing could not be performed.
Event or Problem Description
It was reported that a cancelled procedure occurred.A polaris mmg system was selected for use.During procedure, it was noted that the unit is experiencing image issues.The procedure was not completed due to this event.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: 10417228
• Report Number: 2134265-2020-11133
• Device Sequence Number: 19429664
• Product Code: DQK
• UDI-Device Identifier: 08714729946106
• UDI-Public: 08714729946106
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K151613
• 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): 10/09/2020

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: 0000201261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1