MAUDE Adverse Event Report: ANGIODYNAMICS, INC. SOFT-VU; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	10719708
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During procedure, physician attempted to deploy the embolization coil.Instead of the coil deploying at the end of the catheter it deployed out the side of the tip of the catheter.There was no harm to the patient as a result of this malfunction.

• Brand Name: SOFT-VU
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 9659265
• Report Number: 9659265
• Device Sequence Number: 19746574
• Product Code: DQO
• UDI-Device Identifier: 15051684008716
• UDI-Public: (01)15051684008716
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2020
• Report Date (Section F): 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10719708
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/09/2020