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

Model Number	45038
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Mechanical Problem (1384)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a was selected for a thrombectomy procedure.However, it was noted that the console was not functioning properly and had system error relay.The procedure was cancelled.No patient complications were reported.
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a was selected for a thrombectomy procedure.However, it was noted that the console was not functioning properly and had system error relay.The procedure was cancelled.No patient complications were reported.It was further reported that the issue occurred during preparation and patient was already sedated.It was further reported that it was error 15 "relay test failed to complete" that occurred.
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a was selected for a thrombectomy procedure.However, it was noted that the console was not functioning properly and had system error relay.The procedure was cancelled.No patient complications were reported.It was further reported that the issue occurred during preparation and patient was already sedated.It was further reported that it was error 15 "relay test failed to complete" that occurred.
Additional Manufacturer Narrative
Updated b5 - describe event or problem.Updated: e1 - initial reporter facility name.Updated: d4 - serial number.Device evaluated by mfr.: the ultra console was received in good condition with no physical damages or defects observed.The ultra console was plugged into the wall outlet source and failed a number of test steps.There was display error "relay test failed to complete", during the time of testing.The unit main power was reset at the lower back of the console, but the unit failed.This failure was due a defective power supply relay.The issue was confirmed.
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a was selected for a thrombectomy procedure.However, it was noted that the console was not functioning properly and had system error relay.The procedure was cancelled.No patient complications were reported.It was further reported that the issue occurred during preparation and patient was already sedated.

• 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: 11028142
• Report Number: 2134265-2020-18013
• Device Sequence Number: 13620020
• Product Code: MCX
• UDI-Device Identifier: 08714729890584
• UDI-Public: 08714729890584
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• PMA/510(K) Number: P980037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/30/2021

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: 01/21/2021
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/04/2021; 02/02/2021; 03/09/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/12/2021; 02/24/2021; 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1