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

Model Number 45038

Device Problem Failure to Disconnect (2541)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2020

Event Type  malfunction  

Event Description

It was reported that the footswitch failed to release and the procedure was cancelled.An angiojet ultra 5000a was selected for a thrombectomy procedure.During preparation, it was noted that the unit was operating like the foot pedal is being depressed even though it is not in use.The procedure was cancelled.No patient complications were reported.

Event Description

It was reported that the footswitch failed to release and the procedure was cancelled.An angiojet ultra 5000a was selected for a thrombectomy procedure.During preparation, it was noted that the unit was operating like the foot pedal is being depressed even though it is not in use.The procedure was cancelled.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the ultra foot switch pedal was received by san jose cis in bad condition with physical damages/defects observed.The unit failed visual inspection and mechanical test due to depressed plate on press step test therefore this 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: 10983770
• MDR Text Key: 220676981
• Report Number: 2134265-2020-17241
• 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: 05/24/2021

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: 03/10/2021
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 05/05/2021
• Supplement Dates FDA Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 92069759-FA
• Patient Sequence Number: 1