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

Model Number 45038

Device Problems Failure to Disconnect (2541); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 08/15/2018

Event Type  malfunction  

Event Description

It was reported that the foot pedal was stuck on.An angiojet ultra 5000a console was selected for use with an angiojet catheter.During the procedure, the power pulse functionality was used by pressing the foot pedal.However 3-4 times it happened that after the physician removed his foot from the pedal, the pedal became stuck in the "on" position and it did not release; continuing to activate when they did not want it to.Each time this happened, the employees jiggled the pedal and it released, allowing them to continue to use the pedal for the remainder of the procedure.One single catheter was used along with the console for the entire procedure.There were not issues with the catheter.There was an unspecified issue with the drawer.No patient complications were reported.

Manufacturer Narrative

Device eval by manufacturer: investigation completed on the returned foot switch cable.The foot switch cable was observed to have physical damages/defects.There was a worn out leg pin that caused the foot switch to switch during actions.Investigation revealed no other damages or irregularities.Field service replaced the foot switch in the field.

Event Description

It was reported that the foot pedal was stuck on.An angiojet ultra 5000a console was selected for use with an angiojet catheter.During the procedure, the power pulse functionality was used by pressing the foot pedal.However 3-4 times it happened that after the physician removed his foot from the pedal, the pedal became stuck in the "on" position and it did not release; continuing to activate when they did not want it to.Each time this happened, the employees jiggled the pedal and it released, allowing them to continue to use the pedal for the remainder of the procedure.One single catheter was used along with the console for the entire procedure.There were not issues with the catheter.There was an unspecified issue with the drawer.No patient complications were reported.

• 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: 7833403
• MDR Text Key: 118882159
• Report Number: 2134265-2018-60572
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/08/2019

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: 03/08/2019
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 04/08/2019
• Removal/Correction Number: 92069759-FA
• Patient Sequence Number: 1