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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet console was used for thrombectomy procedure.Upon preparation, the device showed an error 28.The device was removed and restarted but the error persisted.The procedure was canceled due to this event.There were no patient complications reported.
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet console was used for thrombectomy procedure.Upon preparation, the device showed an error 28.The device was removed and restarted but the error persisted.The procedure was canceled due to this event.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr: angiojet barcode reader was received.A visual inspection was done on the barcode reader, and it passed visual inspection.The received barcode reader was installed onto the golden angiojet console.Then a functional test was done, and it failed the functional test.The console booted up to error code 28, and the complaint 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15321032
• Report Number: 2124215-2022-31993
• Device Sequence Number: 14829201
• Product Code: MCX
• UDI-Device Identifier: 08714729890584
• UDI-Public: 08714729890584
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown