MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CONVENIENCE KIT

Catalog Number H9656062093311

Device Problems Air Leak (1008); Fracture (1260)

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

Event Date 01/19/2017

Event Type  malfunction  

Manufacturer Narrative

Although the device from the reported event has been returned to angiodynamics, the device evaluation has not yet begun.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Event Description

As reported by angiodynamics' distributor in the (b)(4), when a hospital was utilizing an angiographic convenience kit for a pci, it was reported that " line at the front of the manifold was skewed bonded, hereby suction of air and leakage.Tried to put on straight, result was that the line broke." there was no report of air being injected or of patient injury.The used device has been returned to angiodynamics for evaluation.

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 may 2017 angiodynamics complaint report was reviewed for the perceptor dts and manifolds product family and the failure mode "air bubbles noted." no adverse trend was identified.Examination of the returned sample showed the male slip of the rotating adaptor of the manifold to be broken off where it is bonded inside the female luer of the contrast injection line (cil).The bond between the female of the cil and the rotating adaptor of the manifold showed no evidence of excess bonding agent.Leak testing could not be performed due to the condition of the returned sample.Based on the sample evaluation results and process controls in place to address this failure mode, possible root causes include the end user trying to tighten the bonded connection, handling damage during transit, or that the responsible employees did not apply enough chemical adhesive when attaching the rotating adaptor.No other damage was noted to the returned sample.The employees involved in the assembly of the reported device lot have been made aware of this event and the applicable bonding procedure has been reviewed with them.(b)(4).

• Brand Name: ANGIODYNAMICS
• Type of Device: CONVENIENCE KIT
• 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: 6328918
• MDR Text Key: 67386173
• Report Number: 1317056-2017-00010
• Device Sequence Number: 1
• Product Code: OEZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: H9656062093311
• Device Lot Number: 5083543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1