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

Model Number	45038
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the footswitch failed to release and the procedure was cancelled.An angiojet ultra 5000a was selected for a thrombectomy procedure.During preparation, it was noted that the unit was operating like the foot pedal is being depressed even though it is not in use.The procedure was cancelled.No patient complications were reported.
Event or Problem Description
It was reported that the footswitch failed to release and the procedure was cancelled.An angiojet ultra 5000a was selected for a thrombectomy procedure.During preparation, it was noted that the unit was operating like the foot pedal is being depressed even though it is not in use.The procedure was cancelled.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the ultra foot switch pedal was received by san jose cis in bad condition with physical damages/defects observed.The unit failed visual inspection and mechanical test due to depressed plate on press step test therefore this issue 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: 10983770
• Report Number: 2134265-2020-17241
• Device Sequence Number: 10938477
• Product Code: MCX
• UDI-Device Identifier: 08714729890584
• UDI-Public: 08714729890584
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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: 03/10/2021
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 05/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 92069759-FA
• Patient Sequence Number: 1