MAUDE Adverse Event Report: VASCATH; CATHETER, HEMODIALYSIS, IMPLANTED

Device Problem Material Twisted/Bent (2981)

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

Event Date 09/29/2020

Event Type  malfunction  

Event Description

A vascath was place in ir.Stem cell called with catheter not working properly.Upon investigation of catheter, a kink was found close to the hub.Vascath was exchanged and catheter sent to risk management.

• Brand Name: VASCATH
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• MDR Report Key: 16853028
• MDR Text Key: 314375418
• Report Number: 16853028
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2023,11/29/2020

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: Other
• 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: 04/19/2023
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Sex: Female