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

Catalog Number H787CT75STSD0

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/26/2018

Event Type  malfunction  

Manufacturer Narrative

As no lot number was reported, a ship history report (shr) was generated for item number h787ct75stsd0 in order to determine the last three lots shipped to the reporting customer in the six months prior to the procedure date.The three lots obtained through the shr were (5046889, 5165202 and 5165459).The device history records for the lots obtained through the ship history report (packaging lots) were reviewed.The review confirms that the lots met all material, assembly and performance specifications.The september 2018 angiodynamics complaint report was reviewed for the smartport product family and the failure mode "difficulty flushing/aspiration." no adverse trend was indicated.Angiodynamics' clinical specialist has been in contact with the reporting physician.The event is being considered a user error, and not a result of a device manufacturing or performance failure.The smart port directions for use contains the statement: "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." ((b)(4)).

Event Description

Angiodynamics received a call on the vascular access clinical hotline from dr.(b)(6), (b)(6) of icu at (b)(6) hospital on (b)(6) 2018.He stated he is caring for a patient that has a 7.5 fr.Smart port which was placed in 2017.Earlier in the day, a nurse in the rehab unit crushed a pill of oral cardizem, mixed it with tap water (volume of tap water it was mixed with unknown), and administered it through the port.He was not sure if a post-medication flush was performed.He stated upon further investigation of the port site, orange precipitate was visualized in the port extension tubing and the port was completely occluded.He also stated that the medication did go through the port and feared there is also drug precipitate in the port reservoir and catheter.Patient is stable and upset that they cannot draw blood from her port for labs.Dr.(b)(6) feels the best course of action is to remove the port rather than contacting the pharmacy for possible alternative solutions.Instructed dr.(b)(6) that if port is removed to return to angiodynamics for investigation.States he will pass that message along to the surgeon.Further information received from dr.(b)(6) indicated that the port was removed on (b)(6) and another port was placed.The surgeon examined the port tubing and did not see any visible drug precipitate in the line.Risk management has taken the port and it is unknown if it will be returned to angiodynamics.The patient condition is stable.

• Brand Name: ANGIODYNAMICS / SMART PORT
• Type of Device: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801
• MDR Report Key: 8085768
• MDR Text Key: 129317238
• Report Number: 1317056-2018-00205
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT75STSD0
• UDI-Public: H787CT75STSD0
• 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 faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H787CT75STSD0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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