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

Catalog Number H787LVTX52130

Device Problem Fluid/Blood Leak (1250)

Patient Problem Apheresis (1719)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

The used device has been returned to angiodynamics, however the investigation has not yet been completed.Upon conclusion of the investigation, a supplemental medwatch will be submitted.((b)(4)).

Event Description

Per end user hospital report: "with one port placement we have noted a significant amount of cross-talk (for example: we find that when flushing one side of a dual lumen port there is blood flow that moves to outward through the other port lumen, which would be unusual.This gives rise to a few possibilities as we can see it.1) there is problem with the port integrity (a crack or breach in the area between the chambers), close proximities of catheter lumen or fluid shift between the catheters further up the tube.This is evidenced by what we see with blood flow as well as the patient is not receiving effective exchange transfusions through apheresis.We do also use your high-flow needles (ref (b)(4)) for accessing the ports".Angiodynamics' original aware date was (b)(6) 2019, but it was originally reported that the port would be left in place.On (b)(6) angiodynamics was notified that the port would be removed and replaced on (b)(6), and the complaint was re-assessed for reportability.The used port has been returned to angiodynamics for evaluation.

Manufacturer Narrative

As no lot number was reported, a ship history report (shr) was generated for item number h787lvtx52130 in order to determine the last three lots shipped to the reporting hospital in the six months prior to the procedure date.The device history records for the lots obtained through the ship history report (5391072, 5400308 and 5405425) were reviewed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The may 2019 angiodynamics complaint report was reviewed for the vortex port product family and the failure mode "lumen leaked." no adverse trend was identified.The port sample was received with the catheter tubing disconnected from the port housing.Functional test: the catheter tubing was connected to the port and water was able to be flushed.The distal tip was pinched and an inter-lumen leak was confirmed approximately 8cm from the port; there was hole/slit in the septum of the tubing.Dimensional: dimensions of catheter od, lumen ids and wall/septum thickness were taken and met specification.The likely root cause of the hole in the septum of the catheter tubing is over-pressurization of one of the lumens during use.This port device was being used for apheresis treatment, however, this port is not indicated for that use in the directions for use provided with the device.Over-pressurization of the lumen via syringe injection (e.G.Smaller than 10cc) or infusion of fluids during the apheresis treatment are potential contributing factors to the hole in the septum.(b)(4).

• Brand Name: ANGIODYNAMICS / VORTEX
• Type of Device: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8413622
• MDR Text Key: 138714187
• Report Number: 1317056-2019-00047
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787LVTX52130
• UDI-Public: H787LVTX52130
• Combination Product (y/n): N
• PMA/PMN Number: K010767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H787LVTX52130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1