MAUDE Adverse Event Report: ANGIODYNAMICS, INC SMART PORT CTSMART PORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHABLE 8.0F X 66; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number H787CT80STPD0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Pocket Erosion (2013); Sepsis (2067)

Event Date 01/01/2024

Event Type  Death  

Event Description

An angiodynamics territory manager reported patients have experienced deshissance of their skin, where the port catheter was tunneled.It was reported that this has occurred multiple times, to different patients, with different providers.This issue has been found to occur 30+ days, past initial port insertion and are not clear infections but moreso erosion and redness tracking up the catheter.Despite multiple good faith efforts to obtain all additional information, minimal details were only provided for two patients; one whom expired from sepsis and another who is experiencing erosion and redness tracking up the catheter.

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).

Manufacturer Narrative

Reference to related event, captured in b5, was inadvertently not included in the initial emdr, 1319211-2024-00011 reference (b)(4) (1319211-2024-00011) for sepsis death and (b)(4) (1319211-2024-00012) for erosion and redness tracking up the catheter.

Event Description

Port had eroded through skin at pocket such that when port was explanted it just fell out of patient pocket.Patient expired a few days after the port explant procedure and root cause of patient expiration was documented as sepsis secondary to port infection.It was reported to be likely that the port will be sent out for cultures; however, no results have been provided.

Manufacturer Narrative

Port had eroded through skin at pocket such that when port was explanted it just fell out of patient pocket.Patient expired a few days after the port explant procedure.Root cause of patient expiration was documented as sepsis secondary to port infection.Patient had a lot of other co-morbidities (no details provided).Port likely sent out for cultures (no details provided).The customer's reported complaint description of patient infection cannot be confirmed given the patient centric nature of this serious adverse event (sae).No port/catheter device was returned for evaluation since there was no report of port/catheter device malfunction, damage or performance issue during use.A review of the device history records for the indicated packaging/assembly/catheter lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Incoming inspection records for catheter tubing lal bacterial endotoxin testing results and sterilization load release records for packaging lot a1923009 were reviewed, no issues observed.Labeling review: the directions for use (dfu) item number 16658102-01 that is provided in the port kit contains the following directions and precautions: 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.Warnings: the device is to be implanted, used, maintained, and removed in strict accordance with institutional and or centers for disease control (cdc) guidelines or policies.Reuse of single-use devices creates a potential risk of patient or user infections.Contamination of the device may lead to injury, illness or death of the patient.Do not use syringes smaller than 10 ml syringe when accessing the port as system damage can occur.Flushing occluded catheters with small syringes can create excessive pressures within the port system.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.Do not attempt to measure the patient's blood pressure on the arm in which a peripheral system is located, since catheter occlusion or other damage to the catheter could occur.If the patient complains of pain, or 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.Precautions carefully read and follow all instructions prior to use.Strict aseptic technique is of paramount importance when implanting any device.Potential complications: use of an angiodynamics port system involves potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to: erosion of vessel and skin.Implant rejection.Infection.Necrosis of scarring of skin over implant area.Vessel trauma.Post-operative care: the incision site should be monitored for signs of infection, inflammation, hematoma, device rotation or erosion.Routine wound care should be given to these sites.The smart port ct implantable port may be used immediately after verification of catheter placement.Instruct patient to avoid any heavy exertion or strenuous activity during the first few days after surgery.General guidelines: each access of an angiodynamics smart port ct implantable port should be performed using aseptic technique.Follow institutional universal precautions.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 CTSMART PORT CT SINGLE TITANIUM PORT SYSTEM WITH ATTACHABLE 8.0F X 66
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• 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: 18747660
• MDR Text Key: 335874822
• Report Number: 1319211-2024-00011
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062414
• 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,Followup,Followup
• Report Date: 03/04/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: H787CT80STPD0
• Device Lot Number: A1923009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 01/25/2024; 02/07/2024
• Supplement Dates FDA Received: 02/21/2024; 03/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR