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

Model Number 45038

Device Problems Display or Visual Feedback Problem (1184); Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2020

Event Type  malfunction  

Event Description

It was reported that loss of aspiration occurred.An angiojet ultra 5000a console was used for a thrombectomy procedure.However, during procedure, it was reported that the unit is not pumping or aspirating.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 the user interface controller showed error (drawer stalled) during the time of testing, and because of this it is impossible to pump or aspirate because the drawer was not sensing the home close position.

Event Description

It was reported that loss of aspiration occurred.An angiojet ultra 5000a console was used for a thrombectomy procedure.However, during procedure, it was reported that the unit is not pumping or aspirating.No patient complications were reported.

Event Description

It was reported that loss of aspiration occurred.An angiojet ultra 5000a console was used for a thrombectomy procedure.However, during procedure, it was reported that the unit is not pumping or aspirating.No patient complications were reported.It was further reported that customer was having issues with roller pump working efficiently.Drawer assembly was replaced but still the pressure issue with the roller pump persisted.It was noted that the roller pump was going in the wrong direction indicating that the issue was on the drawer assembly board or the main control board having issues controlling the roller pump.After replacing the drawer assembly board, the console started working as normal and was ready for use.

Manufacturer Narrative

Updated: b5 - describe event or problem and h6 - device code.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 the user interface controller showed error (drawer stalled) during the time of testing, and because of this it is impossible to pump or aspirate because the drawer was not sensing the home close position.

• 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: 9681539
• MDR Text Key: 179473118
• Report Number: 2134265-2020-01132
• 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,Followup
• Report Date: 09/09/2020

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: 03/23/2020
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: 04/01/2020; 08/25/2020
• Supplement Dates FDA Received: 04/10/2020; 09/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1