MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ANGIOJET SOLENT OMNI 120CMX6F; CATHETER, EMBOLECTOMY

Model Number 109681-001

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2020

Event Type  malfunction  

Event Description

During the setup process of a thrombectomy catheter the machine errored (check fluids) three times.A new catheter was taken up and the same error (check fluids) occurred.A new machine was obtained and the second catheter continued with the check fluid error.A third smaller catheter was opened and the catheter primed without error.A third solent omni with a different lot number was obtained which primed without error.On this catheter the powerpulse technique resulted in more than usual blood in the waste bag.The company rep was notified and requested the catheters be sent back for analysis.Fda safety report id# (b)(4).

• Brand Name: ANGIOJET SOLENT OMNI 120CMX6F
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION ; marlborough MA 01752
• MDR Report Key: 9928026
• MDR Text Key: 186698206
• Report Number: MW5094036
• Device Sequence Number: 1
• Product Code: DXE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/01/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 109681-001
• Device Lot Number: 25033965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1