MAUDE Adverse Event Report: BOSTON SCIENTIFIC ANGIOJET; CATHETER, EMBOLECTOMY

Catalog Number 114610-001

Device Problems Fluid/Blood Leak (1250); Loss of Power (1475); Failure to Power Up (1476); Device Displays Incorrect Message (2591)

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

Event Date 02/03/2017

Event Type  malfunction  

Event Description

During the thrombectomy, the angiojet machine stopped working and had error message "check saline supply" and would not restart.Fluid was seen leaking from the machine.Procedure was stopped and catheter was sent to risk management.

• Brand Name: ANGIOJET
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC; maple grove MN 55311
• MDR Report Key: 6311671
• MDR Text Key: 66921073
• Report Number: MW5067747
• Device Sequence Number: 1
• Product Code: DXE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 114610-001
• Device Lot Number: 19830186
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR