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

Model Number CT66LTPD-VI

Device Problems Malposition of Device (2616); Positioning Problem (3009)

Patient Problem Skin Erosion (2075)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the disposable 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).

Event Description

A technician reported a patient issue with a ct lowprofile smartport.Post procedure, it was noted that the device was completely exposed outside of the patient's skin.The device was placed in 2020 for chemotherapy treatment due to cancer diagnosis.The patient returned for port removal in (b)(6), after the device was found to be exposed.No additional information was able to be obtained.

Manufacturer Narrative

It was reported that the disposable device ihas been returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.(b)(4).

Manufacturer Narrative

Returned for evaluation was one port with catheter tubing attached.As received no visual defects were noted.The port and catheter contained bio material {blood} inside and out.No manufacturing non-conformances were identified during evaluation of the returned port sample.The sample was free of visual defects and leaks.The catheter, stem, and lock met dimensional specifications.No definitive root cause for the patient experience with the port device could be determined.The customer's reported complaint description of port eroded through skin and was exposed could not be confirmed given the patient centric nature of this adverse event.There was no report of port malfunction or leakage during use/access.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 reported failure mode.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.Catheter placement considerations place catheter tip in area of high blood flow.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.Potential complications: drug extravasation (leakage) erosion of vessel or skin necrosis or scarring of skin over implant area 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: 12911777
• MDR Text Key: 281597084
• Report Number: 1317056-2021-00191
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CT66LTPD-VI
• Device Catalogue Number: CT66LTPDVI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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 Sex: Female