MAUDE Adverse Event Report: KING SYSTEM CORPORATION KING LTS-D AIRWAY KIT; AIRWAY, OROPHARYNGEAL

Model Number ZZ-0457

Device Problems Break (1069); Difficult to Insert (1316); Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

An attempt to provide an airway using the king tube was made.At some point during the attempted placement, it was noted that the plastic "weld" that tacks the laryngeal tube to the gastric access lumen of the product had failed.This may have caused the airway to get hung up in the oropharynx and prevent proper placement.The failure of the weld could potentially scrape, inflame, or cause swelling and prevent proper insertion/use of the king tube.Unfortunately, what we don't know is 'at what point did the weld fail?" did they try to place it in the esophagus and the lower portion of the king tube curled on the bottom teeth or tongue thereby breaking the weld between the ng port and the airway section? did it come from the factory broken (unlikely).At this point i think the only thing we can note is that the provider had difficulty placing the king tube, and when it was retracted from the mouth it was noted by the rt assisting that the weld had broken.We don't have more information than that.These airways are designed to blindly enter the esophagus and provide a cuff seal above and below the trachea.They should be quite easy and simple to insert.The ed physician did the insertion and i am not sure if he was familiar with their use.The rt has gone through ooram tms and simulation but has not placed on of these in a live patient.Again, we cannot tell if this is a product issue or a training issue.We would suspect it is a training issue.However, it did seem to occur easily if the tube is allowed to flex opposite the direction of the anterior welded gastric access port.Otherwise the weld seemed quite sufficient for the product when we purposefully tried to separate the two.

• Brand Name: KING LTS-D AIRWAY KIT
• Type of Device: AIRWAY, OROPHARYNGEAL
• Manufacturer (Section D): KING SYSTEM CORPORATION; boise ID 83702
• MDR Report Key: 7211914
• MDR Text Key: 98165379
• Report Number: MW5074701
• Device Sequence Number: 0
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: ZZ-0457
• Device Catalogue Number: REV051716
• Device Lot Number: 10-0027110816
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1