MAUDE Adverse Event Report: ANGIO DYNAMICS ANGIODYNAMIC; VORTEX CT POWER PORT

Model Number CT96STSD

Device Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

Unable to access port.Port study showed retracted tip.

• Brand Name: ANGIODYNAMIC
• Type of Device: VORTEX CT POWER PORT
• Manufacturer (Section D): ANGIO DYNAMICS; latham NY 12110
• MDR Report Key: 4729780
• MDR Text Key: 5664460
• Report Number: MW5042276
• Device Sequence Number: 1
• Product Code: LJT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CT96STSD
• Device Lot Number: 736312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 42