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

Model Number 10712006

Device Problems Difficult to Remove (1528); Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2022

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 8 glens falls technical park; glens falls NY 12801
• MDR Report Key: 15190438
• MDR Text Key: 297521013
• Report Number: 15190438
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 15051684007740
• UDI-Public: (01)15051684007740(17)250531(10)5735835
• 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: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 07/26/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 34310 DA
• Patient Sex: Male