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

Catalog Number H787CT80STPD0

Device Problems Crack (1135); Fluid/Blood Leak (1250); Fracture (1260); Device Issue (2379)

Patient Problems Extravasation (1842); Device Embedded In Tissue or Plaque (3165)

Event Date 12/05/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that the device involved in the incident is not available to be returned to the manufacturer for evaluation.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 available for return.

Event Description

As reported on january 27, 2017 via a user medwatch mw5066849: port placed (b)(6) 2014, was treated with chemotherapy until 2015.The patient was restarted on chemo therapy in 2016.The port was found to be defective and replaced.The catheter was fractured.(this event is reported on medwatch 1056436-2017-00012) second port was implanted a dye study revealed a fracture in catheter.This was explanted and a new catheter was implanted.There was no report of harm or injury to the patient due to this event.It was reported the defective implantable device is not available for return to the manufacturer as it was disposed of by the user.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description is not confirmed, as no sample was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A device history review of the packaging, port assembly and catheter tubing lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.A potential root cause for the catheter fracture may be due to "pinch off syndrome".The directions for use supplied with the device instructs the physician/clinician on how to properly implant the catheter/port, and cautions against certain handling techniques to avoid "pinch-off syndrome".The instructions for use, which is supplied to the user with this catalog number, contains the following statements: potential complications: catheter fragmentation and catheter pinch-off.Catheter placement considerations: 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.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.Note: if infusion or aspiration is successful upon lifting arm above the head and turning the head, consider pinch-off syndrome as a possible cause.The line should be radiologically evaluated if pinch-off syndrome is suspected.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 ; 5187424388
• MDR Report Key: 6325261
• MDR Text Key: 67222821
• Report Number: 1056436-2017-00014
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

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: 08/31/2019
• Device Catalogue Number: H787CT80STPD0
• Device Lot Number: 5074083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2016
• 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