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

Model Number 45038

Device Problems Display or Visual Feedback Problem (1184); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2020

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled.An angiojet ultra 5000a console was selected for a thrombectomy procedure.Before the procedure, it was noted that error 80 or "drawer insert tubing properly" occurred and drawer assembly kept on opening.The procedure was not completed due to this event.No patient complications were reported.

Event Description

It was reported that the procedure was cancelled.An angiojet ultra 5000a console was selected for a thrombectomy procedure.Before the procedure, it was noted that error 80 or "drawer insert tubing properly" occurred and drawer assembly kept on opening.The procedure was not completed due to this event.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the angiojet drawer assembly was received 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 4.26 test steps.The user interface controller showed error (drawer stalled) during the time of testing and because of this the tubing will remain open because the drawer was not fully closed in position during catheter loading.The unit was also found that roller pump pressure value was below the spec, all these problem was not feasible to do a patient procedure therefore all the issue was confirmed.

• Brand Name: ANGIOJET ULTRA 5000A
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10437832
• MDR Text Key: 203883302
• Report Number: 2134265-2020-11447
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 08714729890584
• UDI-Public: 08714729890584
• Combination Product (y/n): N
• PMA/PMN Number: P980037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

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
• Device Operator: Health Professional
• 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: 10/14/2020
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1