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

Model Number 45038

Device Problem Mechanical Problem (1384)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2020

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled.An angiojet ultra 5000a console was used for a thrombectomy procedure.During the preparation, it was noted that the foot pedal was no longer working.No physical damage noted on the foot pedal.The procedure was cancelled.No patient complications were reported.

Event Description

It was reported that the procedure was cancelled.An angiojet ultra 5000a console was used for a thrombectomy procedure.During the preparation, it was noted that the foot pedal was no longer working.No physical damage noted on the foot pedal.The procedure was cancelled.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the ultra foot switch was received in bad condition with physical damages and defects observed.The ultra foot switch failed the functional test.There were bent pins found on a connector socket, therefore the foot switch not working 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: 10846068
• MDR Text Key: 216942901
• Report Number: 2134265-2020-15846
• 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
• Report Date: 05/06/2021

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: 01/13/2021
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 05/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1