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

Catalog Number	H787CT66PTPD0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Angiodynamics has reached out to the complaint reporter in an effort to obtain details of the event.Currently, the nature of the malfunction and patient complications are unknown.Upon the receipt of further information the investigation will be conducted and a supplemental medwatch submitted with the results.(b)(4).
Event or Problem Description
Angiodynamics' legal department received notification from a patient's attorney that a smart port had malfunctioned.The upn and hospital name were provided, but not the nature of the malfunction.A letter with potentially more details is expected.
Additional Manufacturer Narrative
No device history review or ship history review can be performed based on inaccurate information provided.The lot number provided is missing a digit and review of previous lot numbers manufactured for the upn provided did not show any similar looking numbers.In addition, a ship history for the upn provided showed no shipments of that upn to the reported hospital.The recent angiodynamics complaint report was reviewed for the smartport product family and the failure mode "device malfunctioned." no adverse trend was indicated.Despite multiple good faith efforts on the part of angiodynamics, no additional information regarding this complaint has been forthcoming.Without a sample for evaluation it cannot be confirmed either that the reported port malfunctioned or what could have been the root cause of the malfunction.The directions for use packaged with the port provide information/guidance regarding port placement, maintenance, and removal as well as potential complications.(b)(4).

• Brand Name: ANGIODYNAMICS / SMART PORT
• Common Device Name: PORT & CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7272607
• Report Number: 1317056-2018-00010
• Device Sequence Number: 16173907
• Product Code: LJT
• UDI-Device Identifier: H787CT66PTPD0
• UDI-Public: H787CT66PTPD0
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K062414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

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 Catalogue Number: H787CT66PTPD0
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 05/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1