MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) ANGIOJET® ULTRA SYSTEM CONSOLE; CATHETER, CORONARY, ATHERECTOMY

Model Number	105650-001R
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that loss of power occurred to the console.An angiojet ultra system console was selected for use.It was reported that during thrombectomy mode, the console lost power.It was not specified which type of catheter was being used at the time of occurrence.No patient complications were reported and the procedure was completed with another same device.
Additional Manufacturer Narrative
Update: device evaluated by mfr., eval summary attached, method and conclusion codes.Device evaluated by manufacturer: the ultra system with no catheter was received in fair condition with no physical damages/defects observed.Functional testing was performed and the user interface showed a blank display on startup sequence during testing.The ultra main power at the back of the system and barcode assembly light was on but the main control power will not turn on.The ultra system console was reset twice but the main control power failed.A service history review was performed and nothing was found to indicate a possible service-related cause for the complaint.The investigation conclusion isolated the failure to a specific component within a bsc system or assembly which contributed to the event; however the cause for the component failure is unknown.(b)(4).
Event or Problem Description
It was reported that loss of power occurred to the console.An angiojet ultra system console was selected for use.It was reported that during thrombectomy mode, the console lost power.It was not specified which type of catheter was being used at the time of occurrence.No patient complications were reported and the procedure was completed with another same device.

• Brand Name: ANGIOJET® ULTRA SYSTEM CONSOLE
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• MDR Report Key: 7359587
• Report Number: 2134265-2018-02892
• Device Sequence Number: 1392809
• Product Code: MCX
• UDI-Device Identifier: 08714729890607
• UDI-Public: 08714729890607
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P980037
• 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): 02/27/2018

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: 105650-001R
• Device Catalogue Number: 105650-001R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1