MAUDE Adverse Event Report: ANGIODYNAMICS SMART PORT; PORT & CATHETER,

Model Number CT80STPD

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problem Fluid Discharge (2686)

Event Date 02/13/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

Angiodynamics received a letter from a law firm representing a patient regarding a smartport device.It was reported the patient underwent placement of a smartport on (b)(6) 2018 at fairmont regional medical center.The port was for administration of chemotherapy for breast cancer.Clinical/procedural notes indicate when the port was tested after being placed, the port was accessed with good blood return and infusion of heparin saline.It was reported from the first administration of her chemotherapy, nurses immediately experienced difficulty in getting the port to work, requiring many flushes and complex maneuvering to establish flow each time.On (b)(6) 2019, the nurses at united hospital center initiated a flush and observed saline leaking from the patient's chest.The patient was sent for an x-ray, which demonstrated the port appears to be disconnected from the catheter tubing.The patient then underwent angiograms of the port and superior vena cava, which confirmed the hub of the port had separated from the line with extravation of contrast around the pocket.The patient was referred to fairmont regional mc for removal and replacement.On (b)(6) 2019, the patient underwent a procedure to remove left subclavian port and catheter and replace it with a new one.Upon visualizing the port, it was noted the blue hub as well as the catheter was completely off of the port.The entire catheter had been removed, and appeared to be intact.The port was passed off to be returned to the manufacturer.A new port was placed.It was reported the patient was stable post procedure.The reported device is not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description cannot be confirmed, no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.The catheter and blue boot are provided as a separate component within the port assembly kit.The end user attaches the catheter tubing to the port (and secures junction with blue boot) during the implantation procedure.The dfu states: slide the blue strain relief mechanism over the end of the catheter.The tapered end of the blue strain relief mechanism should point away from the proximal end of the catheter.For optimal results, the proximal end of the catheter should be dry.Slide the trimmed end of the catheter tip onto the stem until the catheter is flush with the stem flanges.Slide the strain relief mechanism over the catheter and onto the stem until it contacts the port body.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: the instructions for use, which is supplied to the user with this item 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.Reference (b)(4).

Manufacturer Narrative

The new information received does not impact the investigation results previously submitted on 04/06/2021.Reference (b)(4).

• Brand Name: SMART PORT
• Type of Device: PORT & CATHETER,
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 11528429
• MDR Text Key: 247044064
• Report Number: 1317056-2021-00067
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT80STPD0
• UDI-Public: H787CT80STPD0
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: CT80STPD
• Device Catalogue Number: CT80STPD
• Device Lot Number: 5378436
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/06/2021
• Initial Date FDA Received: 03/19/2021
• Supplement Dates Manufacturer Received: 03/06/2021; 09/22/2022
• Supplement Dates FDA Received: 04/06/2021; 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2018
• 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): Other
• Patient Age: 26 YR
• Patient Sex: Female