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

Catalog Number	CT66LTPD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause for event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
A patient had a smartport device implanted (b)(6) 2015.When presenting for treatment on (b)(6) 2023, there was noted difficulty when attempting to flush the port.This was again noted on (b)(6) 2023.The patient presented for a scan on (b)(6) 2023 which showed the catheter had detached from the port.The port was removed and replaced on (b)(6) 2023.The patient did not experience any adverse effects or harm because of this incident.
Additional Manufacturer Narrative
The reported device is not available to be returned to the manufacturer, for evaluation.An investigation into the root cause for the event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
The customer's reported complaint description of "catheter tubing had detached from the port and port difficulty flushing" cannot be confirmed since no complaint sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Device history review of the packaging, assembly and component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.This smartport was manufactured in our manchester facility, which is no longer in operation.Labeling review: the instructions for use, (16608224-01}) for the smartport device, 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.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.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.Smartport system care guidelines: saline flushes: prior to drug administration, flush the system with saline solution to remove heparin.If more than one drug is administered, flush the system with saline solution between drugs.After patient treatment is completed, always flush the system to cleanse the catheter and port chamber.Heparin flush schedule: to keep the smart port implantable port system patent, the system must be flushed with heparinized saline at regular intervals.Heparin concentration: (10-100 units/ml) of heparinized saline.Typical volume of 3-5 ml.Venous systems: "heparin lock" once every 4 weeks.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).

• Brand Name: SMART PORT CT
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 19020104
• Report Number: 1317056-2024-00057
• Device Sequence Number: 11732690
• Product Code: LJT
• UDI-Device Identifier: H787CT66LTPD0
• UDI-Public: H787CT66LTPD0
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K101017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2024

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: Health Professional
• Device Expiration Date: 10/01/2016
• Device Catalogue Number: CT66LTPD
• Device Lot Number: 606479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 03/11/2024; 05/06/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 04/08/2024; 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Unknown