MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA 5000A; CATHETER, CORONARY, ATHERECTOMY

Model Number	45038
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a was used for a thrombectomy procedure.During procedure, it was noted that system error 56 or actuatuator controller fault error and system error 72 or actuator found moving error occurred.The procedure was cancelled.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the ultra console was received by san jose cis in good condition with no physical damages/defects observed.The ultra console was plugged in to wall outlet source and failed test steps 1.2 to1.14.The user interface controller showed error (56 - actuator controller fault and then error 72 - actuator found moving) during the time of testing.The unit was power reset at the main controller and main power at the lower back of the console, but the system failed.The unit failure was due to bad up/down actuator position sensor that could be corrected during pm calibration, therefore error 56 then later was 72 appeared to be confirmed.
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a was used for a thrombectomy procedure.During procedure, it was noted that system error 56 or actuatuator controller fault error and system error 72 or actuator found moving error occurred.The procedure was cancelled.No patient complications were reported.

• Brand Name: ANGIOJET ULTRA 5000A
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10697768
• Report Number: 2134265-2020-14338
• Device Sequence Number: 3482618
• Product Code: MCX
• UDI-Device Identifier: 08714729890584
• UDI-Public: 08714729890584
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2020

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 Expiration Date: 08/07/2025
• Device Model Number: 45038
• Device Catalogue Number: 45038
• Device Lot Number: OEMTRACE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR