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

Catalog Number H787CT75STSD0

Device Problem Device Issue (2379)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 12/08/2016

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.Complaint reference (b)(4).

Event Description

As reported on (b)(6) 2017: the implant was placed on (b)(6) 2016.When patient returned for a chemo infusion on (b)(6) 2016, they were unable to correctly access mediport and patient complained of discomfort when injecting saline.Notes state that the area was swollen.Treatment was given peripherally for that day.The following day the mediport was removed.A new mediport of the same model was placed on (b)(6) 2017.Records show successful chemo infusions after that date.Patient was being treated for ovarian cancer.There is no prior port placement at this healthcare facility, no images are available, no permanent damage was done, and hospitalization was not necessary, with the exception of the pre-op and post-op time required of placing a new port.It was reported defective device is available for return to the manufacturer for a device evaluation.

Manufacturer Narrative

Returned for evaluation was a single titanium port.As received, the port was returned with the catheter tubing attached and contained bio material inside and out.During functional testing, the port was pressurized to 40 psi and no leak or occlusion was detected.The customer's complaint description of "could not correctly access the port to infuse" cannot be confirmed.An occlusion test determined the port passage is not blocked.There were no manufacturing related defects noted in the returned sample.The sample was evaluated and found to be visually, dimensionally, and functionally acceptable.The customer's complaint does not appear to be a manufacturing related issue.A definitive root cause for the reported complaint description cannot be determined as during functional testing, the device functioned as intended.A device history report review of the packaging and component 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: absence of a blood return or a poor blood return can be a sign of a potential complication such as occlusion, kinking, breakage, pinch-off syndrome, fibrin formation, thrombosis or malposition.This should be evaluated prior to device usage.A blood return should be present prior to usage of device for any therapy or testing.If the patient complains of pain, or if there is swelling when the device is flushed or when medication or contrast media is administered, evaluate the device for infiltration, proper needle placement, and potential complications such as occlusion, kinking, breakage, pinch-off syndrome, thrombosis or malposition.Failure to assess these complaints or observations can lead to device failure.Caution: avoid piercing catheter with suture needle.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 ; 5187424488
• MDR Report Key: 6325258
• MDR Text Key: 67236623
• Report Number: 1056436-2017-00015
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: H787CT75STSD0
• UDI-Public: H787CT75STSD0
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

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: 12/31/2018
• Device Catalogue Number: H787CT75STSD0
• Device Lot Number: 4967889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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