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

Model Number	45038
Medical Device Problem Code	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	10/27/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a console was used for a thrombectomy procedure.During the preparation, it was noted that the foot pedal was no longer working.No physical damage noted on the foot pedal.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 console was used for a thrombectomy procedure.During the preparation, it was noted that the foot pedal was no longer working.No physical damage noted on the foot pedal.The procedure was cancelled.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the ultra foot switch was received in bad condition with physical damages and defects observed.The ultra foot switch failed the functional test.There were bent pins found on a connector socket, therefore the foot switch not working was confirmed.

• 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: 10846068
• Report Number: 2134265-2020-15846
• Device Sequence Number: 3210659
• Product Code: MCX
• UDI-Device Identifier: 08714729890584
• UDI-Public: 08714729890584
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/06/2021

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: 01/13/2021
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1