MAUDE Adverse Event Report: COOK INC AINTREE INTUBATION CATHETER; LRC CHANGER, TUBE, ENDOTRACHEAL

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.

Event Description

The aic was loaded over the fiberoptic bronchoscope and then passed through the clma into the trachea.After confirmation of tracheal placement with the fiberscope, the fiberscope and lma were removed, leaving the aic at the 34 cm mark at the mouth angle.Another manufacturer's endotracheal tube was then introduced over the aic.Unfortunately, the aic broke at the level of the mouth angle and was left in the trachea.The patient regained spontaneous breathing at this time and 3.0 l/min of oxygen was administered by nasal cannula.The facility tried to extract the aic by endoscope, but failed due to the slippery surface of the sheared aic.Ventilation was maintained again by clma.A surgical airway (tracheostomy) was established to remove the aic.Following removal, retrograde insertion of a 16-french nasogastric tube was performed through the orifice of the tracheostomy to the oral cavity.The nasogastric tube served as an introducer and guided the ett into the trachea.The operation progressed smoothly and the patient was discharged uneventfully.

Manufacturer Narrative

Investigation - evaluation.A review of the documentation, instructions for use (ifu) and specifications was conducted during the investigation.The complaint device was not returned; therefore no physical examination could be performed.The lot number of the device is not known; accordingly a review of the device history record could not be conducted.Information received during the course of the investigation indicated that the aintree intubation catheter had been used previously.Per ifu, the device is ¿intended for one-time use.¿ it is possible that handling and usage of the device may have contributed to the reported failure; however, this could not be conclusively be determined.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• Brand Name: AINTREE INTUBATION CATHETER
• Type of Device: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6096892
• MDR Text Key: 59786040
• Report Number: 1820334-2016-01294
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-CAE-19.0-56-AIC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR