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| Model Number |
P5305K |
| Medical Device Problem Code |
Adverse Event Without Identified Device or Use Problem (2993)
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| Health Effect - Clinical Codes |
Bacterial Infection (1735); Chest Pain (1776); Neck Pain (2433); Thrombosis/Thrombus (4440)
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| Date of Event |
04/12/2018
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Type of Reportable Event
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Serious Injury
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Additional Manufacturer Narrative
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The device is not available to be returned to the manufacturer for evaluation.An investigation into the root cause for the event is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
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Event or Problem Description
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On or about (b)(6) 2017, plaintiff underwent placement of an angiodynamics vortex port catheter device, with model number p5305k and lot number 5163667.The device was implanted by dr.(b)(6), m.D., (b)(6) for lack of vascular access.On or about (b)(6) 2018, plaintiff presented to (b)(6) hospital in (b)(6), with complaints of chest and neck pain.Blood cultures were drawn from the port site.Plaintiff was subsequently discharged with a prescription for antibiotics pending results of the blood culture.On or about (b)(6) 2018, plaintiff returned to (b)(6) hospital in (b)(6), due to continued discomfort and the positive blood cultures that were previously drawn.She was discharged home on antibiotics.On or about (b)(6) 2018, plaintiff presented to (b)(6) hospital in (b)(6), due to issues with the antibiotics she had been prescribed.On or about (b)(6) 2018, plaintiff underwent an ultrasound, which demonstrated a thrombosis in her left internal jugular vein.Plaintiff's medical team determined that the vortex needed to be removed due to infection and thrombosis.On or about (b)(6) 2018, plaintiff underwent removal of the defective device.The removal procedure was performed by dr.(b)(6), m.D., at (b)(6) hospital.After her port was removed, plaintiff continued to experience complications and damages resulting from the defective device, including, but not limited to, superior vena cava syndrome.
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Additional Manufacturer Narrative
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Final emdr 1319211-2025-00060 was inadvertently reported under 1319211-2026-00060; therefore, this follow up (#2) is being submitted for the correction.Reference (b)(4).
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Additional Manufacturer Narrative
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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 device was returned for evaluation since there was no report of port device malfunction, damage or performance issue during in situ use/treatment.A device history record (dhr) review of the indicated packaging lot revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Sterilization load release records were reviewed for the packaging lot in question; no issues were observed.The port was implanted into the patient 53 days prior to the patient's infection.There was no report of port device malfunction or performance issue during the implant procedure/use.If the manufacturing/packaging/sterilization of the port device in question was to contribute to an infection in the patient it would have likely occurred shortly after the implant date and not 53 days later.Device directions for use (dfu) cautions that each access of the port should be performed using aseptic technique, following the institutions universal precautions.There is no indication from the reported complaint that the manufacturing/packaging/sterilization of the port device could have contributed to the patient's infection.Infection is cautioned in the device dfu as a potential complication of port system use.Labeling review: the directions for use (dfu) that is provided with the port device contains the following statements: 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.Precautions: carefully read and follow all instructions prior to use.Strict aseptic technique is of paramount importance when implanting any device.For peripheral placement, irritation to the vein, resulting in postoperative thrombophlebitis, has been associated with guidewire and introducer insertion.When using percutaneous introducers: to avoid blood vessel damage, do not allow the percutaneous introducer sheath to remain indwelling in the blood vessel without the internal support of a catheter or dilator.If more than one drug is to be administered, between the individual drug applications, flush the system with 5 to 10 ml normal saline for injection to prevent drug interactions.After any infusion, injection or bolus application, the system should be flushed with normal saline for injection or locked with a heparin solution per institutional protocol to prevent thrombotic occlusion of the catheter.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: air embolism, catheter disconnection or migration, catheter embolization, catheter fragmentation, catheter pinch-off, clot formation, drug extravasation (leakage), erosion of vessel and skin, implant rejection, infection, inflammation, thromboembolism, thrombophlebitis, thrombosis, 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 continues to be monitored for trends.(b)(4).
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Additional Manufacturer Narrative
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Correction: final emdrs (1-2) 1319211-2026-00060 failed due to being a duplicate submission.Final mdr 1319211-2025-00060 for complaint file (b)(4) was inadvertently submitted under 1319211-2026-00060, instead of 1319211-2025-00060; therefore, final mdr for (b)(4) (1319211-2026-00060) failed due to prior error with the wrong submission year.The customer's reported complaint description of patient infection and thrombosis cannot be confirmed given the patient centric nature of this serious adverse event (sae).No port device was returned for evaluation since there was no report of port device malfunction, damage or performance issue during in situ use/treatment.A device history record (dhr) review of the indicated packaging lot revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Certificate of conformance for the sterilization process for the reported packaging lot was verified to be approved at time of distribution.There have been no other reported complaints for the indicated packaging lot for similar patient infection and thrombosis issue.The port was implanted into the patient more than 5 months prior to the patient's infection.There was no report of port device malfunction or performance issue during the implant procedure/use.If the manufacturing/packaging/sterilization of the port device in question was to contribute to an infection in the patient it would have likely occurred shortly after the implant date and not more than 5 months later.Device directions for use (dfu) cautions that each access of the port should be performed using aseptic technique, following the institutions universal precautions.There is no indication from the reported complaint that the manufacturing/packaging/sterilization of the port device could have contributed to the patient's infection.Infection and thrombosis are cautioned in the device dfu as a potential complication of port system use.Labeling review:
the directions for use (dfu) that is provided with the vortex port device contains the following statements:
product description:
ports manufactured by angiodynamics are supplied as sterile devices, and are intended for single patient use only.Indications for use:
the angiodynamics port line is indicated for any patient requiring repeated access of the vascular system for delivery of medications, nutritional supplementation, fluids, blood, blood products, and sampling of blood.Dual models are indicated for combination therapy, simultaneous infusions, withdrawal of body fluids, and bolus delivery during continuous infusion.Contraindications:
angiodynamics port systems should not be implanted in the presence of known or suspected infections, bacteremia, septicemia, and peritonitis, in patients who have exhibited prior intolerance to the materials of construction, or patients whose body size or tissue is insufficient to accommodate the size of the port or catheter.Potential complications:
use of angiodynamics port systems involve potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to:
- clot formation
- embolization
- infection
- implant rejection
- thrombophlebitis
- thromboembolism
- thrombosis
system maintenance:
venous systems
after use, the port should be flushed with at least 20 ml of normal saline.This should be followed by a "heparin lock".If the port is not being used, a "heparin lock" should be administered every 4 weeks.Arterial systems
after use, the port should be flushed with at least 20 ml of normal saline.This should be followed by a "heparin lock".Positive pressure should be maintained on the syringe plunger at all times to minimize reflux of blood into the catheter.If port is not being used, a "heparin lock" should be administered once a week.Peritoneal systems:
the intraperitoneal port should be flushed after use, or once a month if not in use, with 10 ml of heparinized saline at a concentration of 10 units/ml.General guidelines:
· each access of an angiodynamics port should be performed using aseptic technique.· the needle should be advanced through the septum until it contacts the base of the port body.Once positioned in the septum, the needle should not be rocked or tilted.Such movement may cause septum damage.· at no time should the system be left open to air.Tubing clamps should be used to prevent inadvertent air embolism.· when infusing into an angiodynamics port system, do not exceed 40 psi.· do not use a syringe size smaller than 10 ml.Smaller syringes may create an overpressurized system.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint continues to be monitored for trends.Reference (b)(4).
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