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

Catalog Number	H787CT75STSD0
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been indicated that the used port / catheter will be returned to angiodynamics for evaluation, however it has not yet arrived.Upon evaluation of the used device and completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported chest port which had been implanted in (b)(6) 2014 was removed on (b)(6) 2017 in surgery under general anesthesia.After removal, the port was accessed and was noted to be leaking from the tubing and port stem connection.No patient injury was indicated.It has been stated that the used port will be returned to angiodynamics for evaluation.
Additional 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.The recent angiodynamics complaint report was reviewed for the smartport product family and the failure mode, "leak." no adverse trend was identified.The end user hospital's complaint description of leak from the tubing and stem connection could not be confirmed.No sample was returned for evaluation, and without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.The end user attaches the catheter tubing and blue boot to the port during the implantation procedure.The leak at the connection is not likely to be manufacturing related since the port was implanted and in situ for more than 32 months prior to the leak event.The directions for use packaged with the device provide guidance on device assembly, implantation, use, and maintenance.((b)(4)).

• Brand Name: ANGIODYNAMICS / SMART PORT
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• MDR Report Key: 7045502
• Report Number: 1056436-2017-00126
• Device Sequence Number: 16563295
• Product Code: LJT
• UDI-Device Identifier: H787CT75STSD0
• UDI-Public: H787CT75STSD0
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: H787CT75STSD0
• Device Lot Number: 4803712
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 10/31/2017
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR