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

Catalog Number H787CT66LTPD0

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/25/2018

Event Type  Injury  

Manufacturer Narrative

A review of the device history records was performed for the indicated 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.This includes an examination of the records for purchased locking collar component 107158, lot 12028, which was found to meet incoming specifications and has not been referenced in any previous complaints.The recent angiodynamics complaint report was reviewed for the smartport product family and the failure mode "unretrieved device fragments." this does not constitute an adverse trend.In addition, this is the only reported complaint for this failure mode in the past 15 months for the smartport product family.No sample was returned by the reporting hospital, however a phone conference was conducted with angiodynamics and the risk manager and director of surgery at (b)(6) on (b)(6) 2018.The hospital confirmed that it was the locking collar that was removed from the patient.Angiodynamics confirmed for the hospital that the product is a detached port device for which angiodynamics provides the port, catheter tubing, and locking collar loose in the package; the connection is made by the clinician during the port placement procedure.During the port explant procedure, the surgeon reported that the entire port/catheter was removed in one piece.Based on this information, the locking collar would have to have been disconnected from the port housing but still attached to the catheter tubing.Upon removal of the port/catheter the catheter tubing was pulled through the locking collar, leaving the locking collar in the pocket.Tissue growth on the locking collar may have contributed to it being retained in the pocket while catheter was pulled through it.Potential root cause for locking collar becoming detached from the port housing was determined to be one of the following: - locking collar was not securely connected to the port housing during the port implant procedure.- locking collar detached from the port housing while it was in situ.- locking collar was detached from the port housing during the explant procedure.Based on the phone conversation, there is no indication that the device failed to function properly or had been manufactured outside of specification.(b)(4).

Event Description

It was reported that a patient had a smartport implanted and explanted in 2015.It was recently discovered that the metal port collar had been left inside the patient, in the port pocket.The collar was then surgically removed and the patient condition is "ok." the end user hospital submitted voluntary medwatch mw5077076 stating the collar was "a piece of the port that is not detachable." this is not the case, as the port, catheter, and locking collar are provided loose in the port package and the connection is made by the clinician during the port placement procedure.

• 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: 7638670
• MDR Text Key: 112360402
• Report Number: 1317056-2018-00119
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT66LTPD0
• UDI-Public: H787CT66LTPD0
• 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: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: H787CT66LTPD0
• Device Lot Number: 4833273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention