MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CONVENIENCE KIT

Catalog Number H7496566087241

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2017

Event Type  malfunction  

Manufacturer Narrative

It has been indicated that the samples from the reported event will be returned to angiodynamics for evaluation, but they have not yet arrived.Upon receipt of the samples and completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Event Description

As reported by angiodynamics' distributor in the (b)(6), hospital using an angiodynamics kit provided in a (b)(6) procedure pack reported air bubbles in the contrast line, post flushing of the line.No patient injury or complications were reported.The used samples will be returned to angiodynamics for evaluation.

Manufacturer Narrative

A device history records review was performed for the 3 reported kit packaging lots and their 9 associated contrast controller assembly lots.No additional complaints or internal non-conformance reports were associated with any of the lots.The recent angiodynamics complaint report was reviewed for the convenience kit product family and the failure mode "device - air bubbles." no adverse trend was identified.The reported complaint description cannot be confirmed, nor can a definitive root cause be determined, as no sample was returned to angiodynamics.(b)(4) (the distributor) performed initial testing on the complaint samples and observed what they considered to be non-normal flow of contrast into the chamber as a result of excess force needed to aspirate.The potential root cause of the flow problem is a bonding or component issue proximal to the cc chamber, but this cannot be definitively determined without sample evaluation by angiodynamics.The samples forwarded to angiodynamics from the distributor were lost in transit.Angiodynamics' manufacturing process controls for the contrast controller device include visual inspection for molding non-conformities, in-process inspection leak testing, and dimensional verification.The directions for use provided with the device include the following instructions: "ensure that you are making secure connections when using this device to prevent the introduction of air into the system that could result in embolism and in rare instances of death.All connections should be finger tightened.Over tightening can cause cracks and leaks to occur that could result in embolism and or exposure to biohazards.Examine product carefully for entrapped air and fully debubble prior to injection to minimize the potential for embolism and in rare instances death." (b)(4).

• Brand Name: ANGIODYNAMICS
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7169713
• MDR Text Key: 96618455
• Report Number: 1317056-2018-00001
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: H7496566087241
• UDI-Public: H7496566087241
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H7496566087241
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1