MAUDE Adverse Event Report: ANGIODYNAMICS, INC VORTEX; PORT, CATHETER, IMPLANTED

Model Number MP-P5SAT

Device Problems Break (1069); Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

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

Event Date 08/28/2017

Event Type  malfunction  

Event Description

Preoperative diagnosis: port-a-cath malfunction with separation of catheter from port; physician removed port and catheter that was broken at the point the catheter and port attach.Physician/surgeon wants the port to be examined to find out if it was defective.Port is approximately three years old and was placed at another hospital three years ago.Postoperative diagnosis: port-a-cath malfunction with separation of catheter from port; port had been successful until two days ago when it could not be used by the home health nurse.The patient was brought to the emergency room; a peripheral iv was started and he was given his immunoglobulin without difficulty.Subsequently, he presented to surgeon's clinic where review of x-ray demonstrated that the catheter was actually no longer attached to the port explaining the malfunction.

• Brand Name: VORTEX
• Type of Device: PORT, CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS, INC; 1 horizon way; manchester GA 31816
• MDR Report Key: 6900796
• MDR Text Key: 87641836
• Report Number: 6900796
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: MP-P5SAT
• Device Lot Number: 607098
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2017
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 21