MAUDE Adverse Event Report: ANGIODYNAMICS VORTEX CT PORT ACCESS SYSTEM; SMARTPORT CT

Catalog Number H787CT80STPD0

Device Problems Leak/Splash (1354); Device Issue (2379)

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

Event Date 01/13/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.To date the device has yet to be returned.Attempts are being made to obtain the device.An investigation into the root cause for incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.(b)(4) : device not returned to date.

Event Description

As reported on (b)(6) 2017: the implanted port was noted to leak injection contrast when injected.There was no report of permanent patient harm or injury.It was reported defective device is available for return to the manufacturer for a device evaluation.

Manufacturer Narrative

Returned for evaluation was one port and catheter tubing attached.As received the catheter was trimmed to approximately 24 cm and was attached to the port.There was a small gap between the blue boot and the port body with some bio matter in this gap.Leak testing was performed with air at 40 psi through septum with distal tip of catheter clamped, no decay (.00 psi in 7 seconds) was detected.The device met all manufacturing dimensional specifications.The customer's complaint description of leak during injection could not be confirmed.No manufacturing non-conformance were observed during sample evaluation and the catheter tubing met dimensional specifications.No manufacturing related or any other defects were noted during the evaluation.A definitive root cause could be determined.The end user attaches the catheter tubing and blue boot to the port during the implantation procedure.A device history report review of the affected lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.The instructions for use, which is supplied to the user with this catalog number, contains 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.1.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).

• Brand Name: VORTEX CT PORT ACCESS SYSTEM
• Type of Device: SMARTPORT CT
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• Manufacturer (Section G): ANGIODYNAMICS; one horizon way; manchester GA 31816
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 6325279
• MDR Text Key: 67228367
• Report Number: 1056436-2017-00011
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: H787CT80STPD0
• UDI-Public: H787CT80STPD0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: H787CT80STPD0
• Device Lot Number: 5083686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention