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

Catalog Number	H787CT66PTPDVI1
Medical Device Problem Codes	Difficult to Flush (1251); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It has been indicated that the used port will be returned to angiodynamics for evaluation, however it has not yet arrived.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
Angiodynamics notified via user medwatch # (b)(4) of a smart port which was removed/explanted due to the user's inability to flush and draw blood from the device.Another port was implanted.No patient injury was reported.
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 "device occluded." no adverse trend was indicated.Returned for evaluation was the used port body.The catheter tubing was not returned.The port septum showed a minimum of use.Patency testing found no occlusion in the port.The port was also infused ans aspirated without difficulty.The reported port occlusion is not confirmed.The possible reason the physician could not flush or draw is that the catheter was occluded (possibly tip pressed against vessel wall).The catheter was not returned and could not be examined.((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: 8631247
• Report Number: 1317056-2019-00069
• Device Sequence Number: 2017243
• Product Code: LJT
• UDI-Device Identifier: H787CT66PTPDVI1
• UDI-Public: H787CT66PTPDVI1
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K101017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2019

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: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: H787CT66PTPDVI1
• Device Lot Number: 5427425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR