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

Model Number	45043
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a console and an angiojet catheter were used in a thrombectomy procedure.During the procedure, the unit was giving a check saline suppy error message.A drawer replacement was required.The procedure was cancelled.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the ultra console was received in good condition with no physical damages/defects observed.The ultra console was plugged into the wall source with setup catheter and failed some test steps.There was a drawer stalled error on the display, during the time of testing.This drawer failure will create any type of problem during catheter loading and priming.Therefore, the catheter issue during the procedure was confirmed.
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a console and an angiojet catheter were used in a thrombectomy procedure.During the procedure, the unit was giving a check saline suppy error message.A drawer replacement was required.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: 11864200
• Report Number: 2134265-2021-06541
• Device Sequence Number: 17091287
• Product Code: MCX
• UDI-Device Identifier: 08714729890607
• UDI-Public: 08714729890607
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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 Model Number: 45043
• Device Catalogue Number: 45043
• Device Lot Number: U4167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1