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

Catalog Number H787LVTX52130

Device Problem Use of Device Problem (1670)

Patient Problem Pulmonary Embolism (1498)

Event Date 11/10/2017

Event Type  Injury  

Manufacturer Narrative

In lieu of a reported lot number, a ship history report (shr) was generated for item number (h787lvtx52130) in order to determine the last three lots shipped to the reporting hospital.The shr indicated the reporting hospital only received 2 devices {one lot} of this item number since (b)(6) 2012; shipped to the hospital on (b)(6) 2015.This is inconsistent with information that there are 7 reported events.The device history records for the lot obtained through the ship history report (packaging lot) was reviewed.In addition, the corresponding lots for the purchased catheter tubing and connector were reviewed 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 recent angiodynamics complaint report was reviewed for the vortex ports product family and the failure mode "patient injury." no adverse trend was indicated.The reported complaint description cannot be confirmed given the nature of this failure mode.Potential contributing factors that may affect dvt/embolism include the following: high risk patient population, e.G.Oncology.Use of large fr catheter in smaller vessel.Port placement techniques, i.E.Excessive catheter manipulation that can damage the vessel wall.It was reported that the dual lumen port was used for apheresis red cell exchange therapy which is not an "indicated use" of the vortex port per the directions for use (dfu) the dfu includes the following guidance: "indications for use: the angiodynamics port line is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.Dual models are indicated for combination therapy, simultaneous infusions, withdrawal of body fluids, and bolus delivery during continuous infusion."contraindications: angiodynamics port systems should not be implanted in the presence of known or suspected infections, bacteremia, septicemia, and peritonitis, in patients who have exhibited prior intolerance to the materials of construction, or patients whose body size or tissue is insufficient to accommodate the size of the port or catheter.Potential complications: use of angiodynamics port systems involve potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to: infection; occlusion; thrombophlebitis, pneumothorax; catheter malposition; migration and inadequate anchoring; hemorrhage; vessel trauma, including puncture, laceration, and erosion of vessel and the skin; catheter pinch-off (compression of the catheter between the clavicle and the first rib); hematoma; clot formation; catheter fragmentation; embolization; cardiac arrhythmia; cardiac puncture; cardiac tamponade; fibrin sheath, endocarditis; implant rejection; thoracic duct injury; thromboembolism; peritonitis; thrombosis; and drug extravasation (leakage)." ((b)(4)).

Event Description

As reported by physician at hospital in (b)(6) utilizing vortex dual lumen port: "concerning the problems encountered with vortex in sickle cell patients: we have mainly a large problem of jugular thromboses and especially intra cardiac with a significant incidence of 7 thromboses for 18 vortex posed with 2 intracardiac thromboses that have been complicated by pulmonary embolism.These thromboses are most often asymptomatic and detected by trans-thoracic echocardiography and control echo doppler every 6 months in our unit.They occur in patients with an inflammatory profile and for the majority beyond one year of exposure." the ports were being used for apheresis which is not an approved application for this device.All thromboses were treated with xarelto.The port for this patient remains in situ.

• Brand Name: ANGIODYNAMICS / VORTEX
• Type of Device: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801
• MDR Report Key: 7556233
• MDR Text Key: 109622379
• Report Number: 1317056-2018-00080
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787LVTX52130
• UDI-Public: H787LVTX52130
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K010767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: H787LVTX52130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention