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

Model Number 114610-001

Device Problem Defective Device (2588)

Patient Problems Pain (1994); Thrombosis (2100)

Event Date 02/28/2020

Event Type  malfunction  

Event 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¿
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9828881
• MDR Text Key: 183272029
• Report Number: 9828881
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 08714729904724
• UDI-Public: (01)08714729904724(17)210728(10)24365758
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 114610-001
• Device Lot Number: 24365758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/13/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Weight: 114