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

Model Number 114610-001

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 05/24/2018

Event Type  malfunction  

Event Description

There was a small leak in the bulb making the machine malfunction.

• Brand Name: ANGIOJET ZELANTEDVT
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7620029
• MDR Text Key: 111736178
• Report Number: 7620029
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 08714729904724
• UDI-Public: (01)08714729904724(17)200409(10)22083975
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/09/2020
• Device Model Number: 114610-001
• Device Lot Number: 22083975
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1