MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET ULTRA SYSTEM CONSOLE; CATHETER, CORONARY, ATHERECTOMY

Model Number 45038

Device Problems Power Problem (3010); Unexpected Shutdown (4019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/06/2018

Event Type  malfunction  

Event Description

It is reported that a short circuit occurred during use.An angiojet ultra system console was selected for a thrombectomy procedure in the leg.While in use, the console short circuited.No error messages displayed and the console would just turn off.No patient complications were reported.

Event Description

It is reported that a short circuit occurred during use.An angiojet ultra system console was selected for a thrombectomy procedure in the leg.While in use, the console short circuited.No error messages displayed and the console would just turn off.No patient complications were reported.Device evaluated by mfr: as per case number (b)(4), field service found the iec power outlet in poor physical condition.It had signs of impact or strain damage.This caused intermittent electrical connection.The angiojet would randomly loose power.A new iec power outlet was ordered.The console was dismantled and inspected.There were no signs of any other physical damage or fluid ingress.Castors and brakes on wheels were in good operational condition.On the second visit, field service installed the iec power outlet.The console was stripped down in order to complete repairs.The console was reassembled.It passed full functional and electrical safety testing.

• 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: 7819321
• MDR Text Key: 118398521
• Report Number: 2134265-2018-60450
• 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: 11/02/2018

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?: No
• Initial Date Manufacturer Received: 08/06/2018
• Initial Date FDA Received: 08/27/2018
• Supplement Dates Manufacturer Received: 10/30/2018
• Supplement Dates FDA Received: 11/02/2018
• Patient Sequence Number: 1