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

Catalog Number H787CT75STSD0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Type  Injury  

Manufacturer Narrative

In lieu of a reported lot number, a ship history report (shr) was generated for item number (h787ct75stsd0) in order to determine the last three lots shipped to the reporting customer in the six months prior to the procedure date.The device history records for the lots obtained through the ship history report (packaging lots) were reviewed.In addition, the corresponding lots for purchased (sheath/dilator) component item number 106422 were identified.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 "patient injury - air embolism".No adverse trend was identified.No product failure was identified as a device evaluation was unable to be performed.The sheath/dilator is a purchased item for angiodynamics, and the manufacturer, galt medical, has been made aware of this event.The smart port directions for use (dfu) contain the following guidance regarding the use of the sheath/dilator during the port implantation procedure: warnings the device is to be implanted, used, maintained, and removed in strict accordance with institutional and or centers for disease control (cdc) guidelines or policies.During placement through a non-valved introducer sheath, hold thumb over the exposed opening of sheath to prevent air embolism or patient injury may occur.The risk of air embolism is reduced by performing this part of the procedure with the patient performing the valsalva maneuver".((b)(4)).

Event Description

As reported by angiodynamics distributor in (b)(4), "a patient developed an air embolism at the time of the inner dilator was removed before the port tubing was inserted".It was indicated that typically "a proceduralist will attempt to prevent this complication by removing the inner dilator during expiration, to avoid air being sucked into the sheath catheter that remains open to air".No device will be returned for evaluation.The port from the product kit was successfully implanted.

• 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 ; 5187424488
• MDR Report Key: 7780597
• MDR Text Key: 117136344
• Report Number: 1317056-2018-00157
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: H787CT75STSD0
• UDI-Public: H787CT75STSD0
• 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: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: H787CT75STSD0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention