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

Catalog Number H787CT80STPD0

Device Problem No Apparent Adverse Event (3189)

Patient Problem Neck Pain (2433)

Event Date 03/15/2019

Event Type  malfunction  

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 "leaked".No adverse trend was identified.The customer's reported complaint description of "leaked" is not confirmed, as no sample was returned.The (b)(6) 2019 statement from the surgeon indicated that when removed and examined, the port did not leak.The determination was that the symptoms were due to "reflux from the tip of the port back along a fibrin sheath." a replacement port will be placed "deeper within the svc, perhaps even within the atrium." the directions for use for the smart port contain the following placement guidance - "warning: avoid medial catheter placement into subclavian vein through percutaneous technique.This placement could lead to catheter occlusion, damage, rupture, shearing, or fragmentation due to compression of the catheter between the first rib and clavicle.Catheter shearing has been reported when the catheter is inserted via a more medial route in the subclavian vein." (b)(4).

Event Description

As reported by angiodynamic's distributor in (b)(4), a patient had a smart port placed in (b)(6) 2018.It was removed on (b)(6) 2019 "due to cracks".On (b)(6) 2019 the surgeon advised, "i have explanted the port, but despite the study it does not leak.We have determined that it was likely reflux from the tip of the port back along a fibrin sheath and will be replacing it deeper within the svc, perhaps even within the atrium.We appreciate your interest in this patient and her care".On (b)(6) 2019: the surgeon confirmed that the explanted smart port (third port) was discarded and so not available for investigation.

• 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: 8691312
• MDR Text Key: 147870402
• Report Number: 1317056-2019-00074
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: H787CT80STPD0
• UDI-Public: H787CT80STPD0
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K062414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/12/2019

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
• Device Operator: No Information
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: H787CT80STPD0
• Device Lot Number: 5237428
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1