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

Model Number CT75STSD

Device Problem Fracture (1260)

Patient Problems Pain (1994); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 12/06/2022

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 catheter fractured and/or detached cannot be confirmed, as no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.This port product has catheter tubing with a distinct tip end.  since catheter detachment issue occurred within 3 weeks of the port implant procedure an unsecure port catheter connection is potential root cause rather than fracture of the catheter tubing via pinch-off syndrome.  in addition, if catheter tubing (and associated blue boot connector) was attached to the port housing backwards, this could contribute to an unsecure connection.Product analysis would be required to confirm or deny these potential contributing factors.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.Contraindications catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates for pinch-off.Potential complications: catheter fragmentation.Catheter pinch-off.Drug extravasation (leakage).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 nurse/ quality and education director reported an issue with a single titanium ct vtx port placed on (b)(6) 2022.The port was placed in the patient's left subclavian vein.  a patient presented to a cancer center ((b)(6) 2022) for an infusion; however, the nurse was unable to draw blood from port; therefore, a chest x-ray was obtained, per the center protocol.  the x-ray noted that a portion of the tubing of the implanted port had broken off and was lodged in the patient's heart.  (b)(6) 2022 the patient was taken to the emergency room where she was subsequently transferred to another facility in order to have the portion of tubing removed.  unknown if same or different device was placed after removal.The patient reported the day prior to this event, that she was experiencing chest discomfort, which she believed to be related to anxiety, so she treated with xanax.After taking the medication, the pain resolved.  as of (b)(6) 2022, the patient has been discharged from the hospital and is doing well.Additional information provided reported it was unknown how often the port was accessed.Also provided were the patient medications.Prior to presenting to the cancer center on the day of event, patient reported that the same chest pain had returned but only for a short time.

• 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: 16052372
• MDR Text Key: 306182326
• Report Number: 1317056-2022-00149
• Device Sequence Number: 1
• Product Code: LJT
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/27/2022

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 Model Number: CT75STSD
• Device Catalogue Number: CT75STSD
• Device Lot Number: 5693831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2021
• 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
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic