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

Model Number	10712006
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Mid 90¿s male with history of recent acute blood loss anemia and gi bleed.Procedure: arteriogram through right groin.The angiodynamics twisted and kinked, inside the patient's vessel.It was very difficult to remove from the sheath.Device was removed intact, without known harm to patient.

• Brand Name: SOFT-VU
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 8 glens falls technical park; glens falls NY 12801
• MDR Report Key: 15190438
• Report Number: 15190438
• Device Sequence Number: 5634148
• Product Code: DQO
• UDI-Device Identifier: 15051684007740
• UDI-Public: (01)15051684007740(17)250531(10)5735835
• 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): 07/26/2022
• Report Date (Section F): 07/26/2022

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: 10712006
• Device Lot Number: 5735835
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 07/26/2022