MAUDE Adverse Event Report: ANGIODYNAMICS VORTEX MP VASCULAR ACCESS PORT; VORTEX¿ MP VASCULAR ACCESS PORT

Catalog Number	H787SPAX16I0
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Angiodynamics has received notification that we no longer are eligible to participate in the alternative summary (asr) program for the product families of vortex and smartport.This retrospective mdr is being filed at this time based on the new ineligibility notice, dated june 12, 2017.As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of "catheter fracture" is not confirmed, as no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.The most likely root cause of this catheter fracture event is pinch-off syndrome.The instructions for use, which is supplied to the user with this catalog number, contains warning regarding "pinch-off syndrome" in the following statements: caution: it is extremely important to adequately flush the port after blood withdrawal.Occlusion of the catheter can occur if blood is left in the catheter for an extended period of time.· power injection should not be performed if blood aspiration is not present or the port is difficult to flush.If the implanted port is utilized, it may result in device failure or patient injury.Two-way obstruction (unable to infuse through the port system and unable to aspirate blood): causes · a fibrin tail, clot or sheath may be on or within the catheter.· the non-coring (huber point) needle may not be patent or properly positioned within the port septum.· confirm that the needle is of sufficient length and, when positioned in the septum, the needle opening is not occluded by the septum.· the clamp on the non-coring (huber point) needle should be open.· a drug precipitate caused by incompatible drugs infused through the port may be obstructing the system.To prevent, use adequate amounts of sterile normal saline between incompatible solutions.· a thrombolytic agent may be used on the order of a physician to restore patency.The procedure should be outlined by the drug manufacturer's labeling.Use facility protocol to determine which thrombolytic agent to use.· the use of streptokinase has been known to cause allergic and anaphylactogenic reactions.· a contrast study performed through the port may confirm fibrin sheath presence, kinking, malposition, or pinch-off syndrome.Caution: do not force solutions through the port system to clear an obstruction.A high pressure situation may cause irreversible catheter damage, leading to port system explant.Pinch-off syndrome pinch-off syndrome signs may include difficulty in aspirating blood, resistance to flushing or infusion of medications or fluids that improves with position changes, infraclavicular pain and/or swelling with catheter flushing or infusion palpitations, sudden onset chest pain, cardiac arrhythmias, extra heart sound, chest wall swelling at the port pocket, vein insertion site, pain in shoulder or port area not associated with swelling, cough, paresthesia of arm on side of catheter withdrawal occlusion or swishing sound with catheter flushing.Warning: avoid medial catheter placement into subclavian vein through percutaneous technique.This placement could lead to catheter occlusion, damage, rupture, shearing, or fragmentation due to compression of the catheter between the first rib and clavicle.Catheter shearing has been reported when the catheter is inserted via a more medial route in the subclavian vein.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint reference (b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2016 via user medwatch (b)(4): patient had a right internal jugular vein port-a-cath placed approximately 2 weeks prior.There were no complications on placement and device flushed easily.Patient received one round of chemotherapy with device.During subsequent admission, it was found that the port would not flush.On x-ray, it was discovered that the catheter was fractured.Device was successfully removed, and found to be bent, had partially broken through.It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.

• Brand Name: VORTEX MP VASCULAR ACCESS PORT
• Common Device Name: VORTEX¿ MP VASCULAR ACCESS PORT
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• MDR Report Key: 6706024
• Report Number: 1056436-2017-00064
• Device Sequence Number: 11041804
• Product Code: LJT
• UDI-Device Identifier: H787SPAX16I0
• UDI-Public: H787SPAX16I0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K010189
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: H787SPAX16I0
• Device Lot Number: 4970059
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2017
• Initial Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1