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

Catalog Number	H787CT66PTPD0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	07/16/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The reported packaging lot (5341814) for item number h787ct66ptpd0 was reviewed for the indicated packaging and component lots for any deviations related to the reported complaint event.The review confirms that the lots met all material, assembly and performance specifications.There have been no previously reported complaints for packaging lot 5341814 or purchased catheter tubing component lot {644185} for similar issues.The recent angiodynamics complaint report was reviewed for the smartport product family and the failure mode "patient death".No adverse trend was indicated.This is the only occurrence in the past 15 months and, as such, this is deemed to be an isolated incident.The port was not returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine whether there is a relationship between the device and the reported event (patient death.) dhr review of the packaging and component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.The statement received from the risk manager indicated that there was no device malfunction and the patient death was believed to be from the "disease process".((b)(4)).
Event or Problem Description
As reported by hospital, "july 16th outpatient procedure for a mediport placement to be performed by dr.(b)(6).The patient was diagnosed with multiple myeloma.The mediport was placed, no difficulty was completed on first attempt.Procedure was approx 30 minutes, patient was awakened with no issues and taken to recovery.This is where he became restless, unresponsive and pulse less.Cpr was started and after multiple attempts the patient did not respond and expired at 9:47.The coroner arrived and an autopsy will be done".Follow up phone call with risk manager indicated that the patient death was believed to be due to the "disease process," not to port (device) malfunction.

• 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: 7806408
• Report Number: 1317056-2018-00160
• Device Sequence Number: 1350958
• Product Code: LJT
• UDI-Device Identifier: H787CT66PTPD0
• UDI-Public: H787CT66PTPD0
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: H787CT66PTPD0
• Device Lot Number: 5341814
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 63 YR