MAUDE Adverse Event Report: ANGIODYNAMICS, INC SMART PORT CT; SMART PORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHED 7.5F X 66CM SILICONE CAT

Catalog Number CT75STSA

Device Problem Fracture (1260)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint description of port catheter tubing fractured and detached cannot be confirmed, no complaint sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: the instructions for use item number {16608102-01}, 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).

Event Description

A distributor reported the following: "on (b)(6) 2024, we have been notified by msa's territory manager of an incident involving the removal/explant of a smart port (ref:(b)(4)) and catheter fracture.The port in question was implanted on (b)(6) 2023 in the left subclavian (female, 44y.O., 70kg) and (b)(6) december 2023 (i.E.48 days in situ).Implantation and explanation were performed by the same doctor at the same hospital facility.The reason for removal of the smart port was reportedly due to "irritation" experienced by the patient.The patient had "routine admission on (b)(6) 2023 for removal of infusaport 0800.On withdrawal of the catheter, surgeon noted: "catheter was fractured!" patient recovered and remained fasting and admitted to angio for removal of the fragment (b)(6)2023 at 1330hrs." due to this the patient had an unplanned overnight hospital admission (i.E.Prolonged hospitalization).It has been confirmed with the hospital, due to the delayed reporting of this incident to msa, the hospital has not retained the explanted smart port for further investigation.

• Brand Name: SMART PORT CT
• Type of Device: SMART PORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHED 7.5F X 66CM SILICONE CAT
• 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: 18904296
• MDR Text Key: 337757534
• Report Number: 1317056-2024-00050
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT75STSA0
• UDI-Public: H787CT75STSA0
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K062414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: CT75STSA
• Device Lot Number: 5779703
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 70 KG