MAUDE Adverse Event Report: ANGIODYNAMICS, INC. ACCUVU; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 13709803

Patient Problem Insufficient Information (4580)

Event Date 08/08/2023

Event Type  malfunction  

Event Description

The catheter was kinked at the tail portion and could not pass a wire through it.Had to discard and get a new one.

• Brand Name: ACCUVU
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 603 queensbury ave.; queensbury NY 12804
• MDR Report Key: 17555468
• MDR Text Key: 321233509
• Report Number: 17555468
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/09/2023

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: 13709803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female