MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA SYSTEM CONSOLE; 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 05/24/2020

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled.Two angiojet solent catheters and an angiojet ultra system console were selected for use.During preparation, fluid was leaking out of the console where the catheters are attached.A check saline supply error displayed.The drawer did not initially close on the console.The procedure was cancelled.No patient complications were reported.

Manufacturer Narrative

Device analysis by mfr: the angiojet ultra system console was investigated.The drawer was found to be out of alignment.The thrombectomy set would not load properly, resulting in it leaking.The drawer was realigned and recalibrated pressure setting from the actuator.Full preventative maintenance was completed and the console passed full functional and electrical safety testing.

Event Description

It was reported that the procedure was cancelled.Two angiojet solent catheters and an angiojet ultra system console were selected for use.During preparation, fluid was leaking out of the console where the catheters are attached.A check saline supply error displayed.The drawer did not initially close on the console.The procedure was cancelled.No patient complications were reported.

• Brand Name: ANGIOJET ULTRA SYSTEM CONSOLE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10158065
• MDR Text Key: 195256853
• Report Number: 2134265-2020-08017
• Device Sequence Number: 1
• Product Code: MCX
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/11/2020

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: U3501
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2020
• Initial Date FDA Received: 06/16/2020
• Supplement Dates Manufacturer Received: 07/22/2020
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1