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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city - (b)(6).

Event Description

It was reported that the procedure was cancelled.An angiojet ultra system console and angiojet catheter were selected for a thrombectomy procedure.During the preparation, the catheter was properly loaded on the console however, it was impossible to close the drawer.The drawer was blocked.System error 82 "drawer run stop failure" occurred.The patient can not undergo other treatment other than the angiojet so the procedure was rescheduled the next day.No patient complications were reported.

Manufacturer Narrative

E1: initial reporter city - (b)(6).Device evaluated by mfr.: the angiojet console was returned in good condition.The unit failed the angiojet basic functional test.The drawer's roller pump assembly failed to open.

Event Description

It was reported that the procedure was cancelled.An angiojet ultra system console and angiojet catheter were selected for a thrombectomy procedure.During the preparation, the catheter was properly loaded on the console however, it was impossible to close the drawer.The drawer was blocked.System error 82 "drawer run stop failure" occurred.The patient can not undergo other treatment other than the angiojet so the procedure was rescheduled the next day.No patient complications were reported.It was further reported that the patient was treated by a vascular surgeon doing fogarty procedure.

• 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: 11479069
• MDR Text Key: 239699301
• Report Number: 2134265-2021-02962
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• 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: 03/31/2021

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: U8824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/14/2021
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1