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

Model Number 8864

Device Problem Computer Software Problem (1112)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/28/2020

Event Type  malfunction  

Event Description

It was reported that polaris cannot boot up occurred.The target lesion was located in the coronary artery.A polaris mmg system was used.During preparation.The technician wants to start up polaris but was unable to boot up.The screen showed nothing so they decided to cancel/reschedule the procedure.Patient was already sedated when the problem occurred but patient was stable.

• Brand Name: ILAB POLARIS MULTI-MODALITY GUIDANCE SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 150 baytech dr.; san jose CA 95134
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10083296
• MDR Text Key: 191846589
• Report Number: 2134265-2020-06321
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 08714729946106
• UDI-Public: 08714729946106
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K151613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2020

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
• Device Operator: Health Professional
• Device Model Number: 8864
• Device Catalogue Number: 8864
• Device Lot Number: 0000201236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1