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

Model Number 45037

Device Problems Defective Device (2588); Difficult to Open or Close (2921); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1: (b)(6).

Event Description

It was reported that the procedure was cancelled.The target lesion was located in the renal artery.An angiojet console was used in a thrombectomy procedure.During the procedure while in power pulse mode, the machine stopped working and the machine start rebooting by itself.The console did not turn on completely, as soon as it was turned on, the tray table starts to come out and then the machine turns off.The patient was already sedated and the procedure was cancelled.No patient complications were reported.

• 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
• Manufacturer (Section G): EUROPEAN DISTRIBUTION CENTER; vestastraat 6; kerkrade 6468 EX; NL 6468 EX
• Manufacturer Contact: jay johnson johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12108222
• MDR Text Key: 259646728
• Report Number: 2134265-2021-08310
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/02/2021

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: 45037
• Device Catalogue Number: 45037
• Device Lot Number: U9297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1