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 01-jan-2012; shipped to the hospital on 06-may-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).
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