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); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a was advanced for treatment.However, before it was advanced for thrombectomy procedure, an error occurred stating that the wrench indicator light was on and would like it serviced.The procedure was cancelled due to this event.No patient complications were reported.
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a was advanced for treatment.However, before it was advanced for thrombectomy procedure, an error occurred stating that the wrench indicator light was on and would like it serviced.The procedure was cancelled due to this event.No patient complications were reported.
Additional Manufacturer Narrative
Updated: h6 - device codes.
Event or Problem Description
It was reported that the procedure was cancelled.An angiojet ultra 5000a was advanced for treatment.However, before it was advanced for thrombectomy procedure, an error occurred stating that the wrench indicator light was on and would like it serviced.The procedure was cancelled due to this event.No patient complications were reported.
Additional Manufacturer Narrative
Updated: h6 - device codes.Device evaluated by mfr.: the angiojet drawer assembly was received in san jose cis in good condition with no physical damages observed.Ultra system console and catheter were not returned for analysis.The drawer was installed into ultra system test fixtures and failed 4.7 to 4.12 test steps.The user interface controller showed error (drawer stalled) during the time of testing.The red wrench indicator light appeared momentarily before the drawer stalled therefore defective drawer assembly 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: 11985202
• Report Number: 2134265-2021-07155
• Device Sequence Number: 19791182
• Product Code: MCX
• UDI-Device Identifier: 08714729890584
• UDI-Public: 08714729890584
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2021

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: 07/07/2021
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 07/01/2021; 07/22/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 07/20/2021; 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1