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

Model Number CT75STSD

Device Problem Fracture (1260)

Patient Problems Chest Pain (1776); Decreased Respiratory Rate (2485); Foreign Body In Patient (2687)

Event Date 02/23/2022

Event Type  Injury  

Manufacturer Narrative

As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of "tubing from the port had broken off and was lodged in the patient's heart" is not confirmed, as no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A potential root cause for a detached catheter tubing that has been in situ for more than nine (9) months is pinch-off syndrome, which is cautioned in the dfu as an anticipated procedural complication.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).

Event Description

A customer called and reported a patient had experienced an issue with a port.The port had been placed in (b)(6) 2021, and a chest x-ray in (b)(6) 2021 showed the port was fine with no noted issues.The catheter was tunneled through the clavicle.Patient presented to cancer center for a chemotherapy infusion.When port was flushed with minimal pressure, the patient became short of breath and complained of chest pain.She was taken to the er where a chest x-ray was taken and showed a portion of the tubing from the port had broken off and was lodged in the patient's heart.The patient was transferred to the emergency room where she was transferred to another facility to have the portion of tubing removed.It was reported that three attempts were made to remove the catheter, and on the third attempt, they were able to remove the fragment via groin access.At the time of reporting this issue, the port body was still implanted.It is unknown if the catheter fragment was retained or disposed of.It was reported the patient was released the day after the fragment was removed and is doing well.

Manufacturer Narrative

A1.Patient initials: (b)(4).B5.Upon discovery of the fracture, patient was life-flighted from troy regional medical center to baptist medical center south in montgomery, alabama where she was admitted at approximately 12:56 p.M.On (b)(6) 2022.The patient subsequently underwent two procedures to remove fragments of the fractured catheter from her heart and was discharged on (b)(6) 2022.B7.Patient underwent port implantantion for infusion therapy for thrombotic thrombocytopenic purpura.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: 13802452
• MDR Text Key: 292508854
• Report Number: 1317056-2022-00057
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT75STSD0
• UDI-Public: H787CT75STSD0
• 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: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: CT75STSD
• Device Catalogue Number: CT75STSD
• Device Lot Number: 5596070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2020
• 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; Hospitalization
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 173 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American