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

Model Number CT80STPD-VI

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

Patient Problems Wound Dehiscence (1154); Skin Erosion (2075); Post Operative Wound Infection (2446)

Event Date 03/29/2021

Event Type  Injury  

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).

Event Description

A technician reported an issue in a patients with a ct w/8fr det poly cath w/vi smartport.Post placement procedure, the patient was found to have wound dehiscence, port pocket infection, and skin erosion.The port was removed due to these issues, and the doctor believes the causes are multifactorial, but cannulation technique is likely playing a role.The customer has recently instituted a pre-procedure hibiclens protocol to reduce the risk of infection; however, they are not exactly sure what is causing this as it's never happened throughout the years.The physician is still looking to uncover the cause as it's the same port, same physician and placement technique since 2018.Additional information obtained reported the chemo infusion for the patient is performed by an infusion service and not the reporting customer.The customer has indicated they will provide an "in-service" with the nurses at the referring facilities.The reported device is not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description cannot be confirmed given the nature of this serious adverse event (sae).A root cause for the reported event cannot be determined.The catheter and lock are provided as a separate component within the port assembly kit.The end user attaches the catheter tubing to the port (and secures junction with lock) during the implantation procedure.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.One step locking mechanism: slide the locking mechanism over the proximal end of the catheter, leaving 1 to 2 cm of catheter protruding.Advance the catheter completely over the stem.Slide the lock up to the port body and "snap" into the port.J.Secure port body to underlying fascia using non-absorbable sutures and a minimum of three suture sites.Care should be exercised so that incision does not cross septum of port after closure.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
• MDR Report Key: 11648305
• MDR Text Key: 244891007
• Report Number: 1317056-2021-00085
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT80STPDVI1
• UDI-Public: H787CT80STPDVI1
• Combination Product (y/n): N
• PMA/PMN Number: K101017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CT80STPD-VI
• Device Catalogue Number: CT80STPDVI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other