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

Model Number	114610-001
Health Effect - Clinical Codes	Pain (1994); Thrombosis (2100)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of hypertension and type 2 diabetes.Left leg pain for 2 days, positive deep vein thrombosis.Undergoing left lower extremity percutaneous thrombectomy with angiojet and genioplasty.During the procedure, the angiojet was sucking instead of spraying tpa on the appropriate setting.Device removed without harm to the patient.

• Brand Name: ANGIOJET¿ ZELANTEDVT¿
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9828881
• Report Number: 9828881
• Device Sequence Number: 2886063
• Product Code: DXE
• UDI-Device Identifier: 08714729904724
• UDI-Public: (01)08714729904724(17)210728(10)24365758
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/03/2020
• Report Date (Section F): 03/03/2020

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
• Operator of Device: Health Professional
• Device Model Number: 114610-001
• Device Lot Number: 24365758
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2020
• Patient Sequence Number: 1
• Patient Weight: 114
• Date Report Sent to FDA: 03/03/2020