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

Model Number CT66LTPD-VI

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

Patient Problems Fever (1858); Sepsis (2067); Confusion/ Disorientation (2553)

Event Date 05/09/2022

Event Type  Injury  

Event Description

This medwatch is not to report a device malfunction, but to report an adverse patient effect post procedure.There was no report of a device malfunction or patient complication during the port placement procedure or during use of the port.A patient experienced an issue when using a ct low profile with valved introducer smart port.The patient had been diagnosed with left breast invasive ductal carcinoma with axillary lymph node involvement, therefore, a smart port vortex safe sheath ultra lite port was implanted (right internal jugular) on (b)(6) 2022 at (b)(6)hospital.The port never felt right to the patient.On (b)(6) 2022, the patient received chemotherapy and immunotherapy (ptch ) at a chemo infusion center.The port connector was accessed once for a blood draw and once to administer chemo.It was cleaned with alcohol before use both times.On (b)(6) 2022, patient developed low grade fever (100.4).The patient called the on call physician who informed the patient to take tylenol and call back if temperature gets worse.Over the next couple of days ((b)(6) 2022 through (b)(6) 2022), the patient became progressively delirious/confused.On (b)(6) 2022 the patient was taken by ambulance to the er at (b)(6) hospital.The patient presented at er with fever (100.2), encephalopathy and fatigue.The er assessed the patient with the following results: severe sepsis, neutropenic fever, hyponatremia, thrombocytopenia, lactic acidosis, dehydration, likely hypovolemic, siadh also possible, acute kidney injury (aki).The patient was determined by er doctor to be at high risk for morbidity and mortality.The patient was admitted to the hospital where she remained from (b)(6) 2022 through (b)(6) 2022 for mssa bacteremia presumed from infected port-a-cath.Patient testing resulted in the following: blood cultures: methicillin susceptible staphylococcus aureus (mssa) bacteremia.Wound culture from right chest: mrsa.Catheter tip: staph aureus.On (b)(6) 2022, the port was removed.Directly after removal patient experienced rigors.On (b)(6) 2022, the patient was discharged from hospital on iv ancef 2 g q 8 hours for 2 weeks.The port was not replaced, and the patient received treatment via ivs.The wound left by the port took 3 months to close and is still in the process of granulating in.While the port did not look healthy at the connector site, there was no difficulty with using it.At the time of receiving this additional information, it was reported the patient was fully recovered regarding this event.

Manufacturer Narrative

It was reported that the device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of patient infection cannot be confirmed given the patient centric nature of this serious adverse event.No port/catheter sample was returned for evaluation since it was reported there was no difficulty in using the device.A review of the sterilization paperwork shows no concern that patient infection was a result of the port device itself.Potential root cause of the patient infection is the port placement procedure, which is cautioned in the dfu.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 any failure mode (includes sterilization cycle non-conformances).Sterilization paperwork review: a review of the sterilization cycle paperwork was performed and all parameters met per csa specification.There was no adverse impact on the product or the sterilization process.Labeling review: the instructions for use, which is supplied to the user with this item number, contains the following statements: general guidelines the following suggestions for surgical insertion are provided as an aid to facilitate safe and prolonged use of the angiodynamics port systems.The smart port family of ports may be placed in a number of areas of the body and the catheter may be placed in a variety of vessels or other selected sites.Use the surgical procedure and the sterile technique which best suits your application and is appropriate for the patient.Angiodynamics recommends that the patient, when appropriate, be placed in the trendelenburg position.Port and catheter preparation: prime the port system prior to placement using 10 ml of normal saline or heparinized saline (100 units/ml).Attach the non-coring (huber point) needle to the syringe, penetrate the septum of the port, and flush the system.Warning: use a 10 ml or larger syringe when administering fluid into system.Port placement considerations: placement needs to be supported by underlying bony structure.A minimum of three sutures should be used to secure port body.Port location should be convenient and comfortable to the patient.Avoid placing port system directly under port pocket incision.Avoid placing port too deep or too shallow (minimum 0.5 cm - maximum 2 cm under skin surface).Pre-operative mapping of location is recommended whenever possible.Precautions: carefully read and follow all instructions prior to use.Strict aseptic technique is of paramount importance when implanting any device.Before handling the port, ensure that fingers of surgical gloves are free of talc.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: these complications are well documented in literature and should be considered when a venous access device is utilized.Potential complications: drug extravasation (leakage), erosion of vessel or skin, necrosis or scarring of skin over implant area, infection, inflammation.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
• 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: 15454386
• MDR Text Key: 300225780
• Report Number: 1317056-2022-00116
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT66LTPDVI1
• UDI-Public: H787CT66LTPDVI1
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: CT66LTPD-VI
• Device Catalogue Number: CT66LTPDVI
• Device Lot Number: 5728873
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/09/2022
• Initial Date FDA Received: 09/20/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 66 KG