MAUDE Adverse Event Report: COOK INC COOK AIRWAY EXCHANGE CATHETER; LRC CHANGER, TUBE, ENDOTRACHEAL

Model Number N/A

Device Problem Off-Label Use (1494)

Patient Problems Cardiac Arrest (1762); Death (1802); Hypoxia (1918); Pneumothorax (2012); Brain Injury (2219)

Event Date 12/05/2019

Event Type  Death  

Manufacturer Narrative

Date of death: the patient was reported to have died "a few weeks" after the event.Exact date of death is currently unknown.Pma/510(k) #: exempt.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was initially reported that the customer had "an incident" with an aintree intubation catheter.The incident was with the catheter, which was reported to have been "put [through] a tracheotomy stoma" and then "jet ventilated".Additional information confirmed that the device was "used to aid with a tracheostomy change in theatre".A manujet ventilation device was attached to the catheter via a rapid-fit adapter (which is supplied with the aintree intubation catheter).Jet ventilation was used while the new tracheal tube was inserted.The patient was then reported to have coughed.Immediately, the patient deteriorated and suffered from bilateral pneumothoraxes and cardiac arrest.Bilateral needle decompressions and subsequent chest drain insertions led to the return of circulation.However, the patient ultimately had a severe hypoxic brain injury and died a few weeks following the event.The cause of the severe hypoxic brain injury and death is unconfirmed at this time.Additional information regarding the patient, event, and device has been requested but is unavailable at the time of this report.

Event Description

Additional information regarding the patient, device, and event was received on (b)(6)2020 and (b)(6) 2020 after a meeting at the user facility's mri anesthetic department between two consultant anesthetists, a cook representative, and a cook product manager.A cook airway exchange catheter was being used to exchange a size 8 portex tracheostomy tube for a size 7 portex tracheostomy tube.This specific device was selected to "provide a conduit to exchange the tracheostomy tube".The surgical procedure was being performed to stop the arterial bleeding.During the procedure, it was decided that a "longer, adjustable flange tracheostomy tube" was needed, so the size 7 tube was removed over the device.The physician then attempted to insert the size 8 flange tube over the device; however, the patient coughed during, resulting in a pressure change in the patient's airway.As a result, the patient's blood pressure and oxygen saturation started to drop.A luer-lock rapi-fit adapter was attached and oxygen was delivered using a "manujet at 2.5 bar, the lowest adult setting on the manujet".Following this series of events, the patient had "massive bilateral pneumothorax" and then suffered from cardiac arrest as a result.The patient was then resuscitated.During the procedure, the position of the aec was confirmed through "close watch on cm markings" on the device.The device was placed through a tracheostomy tube, which was then removed.The position of the device relative to the carina was presumed to be above but was not formally assessed.A nasal endotracheal tube was in place additionally so that the tracheostomy could be safely removed.At the time of the incident, the nasal endotracheal tube was not being used as the tracheostomy had been reinserted.The patient was ventilated during this portion of the procedure which "continued for the time of the case".Major surgery was said to be the underlying condition that lead to the need for prolonged ventilation.It was reported that "prior to the second procedure for bleeding from the tracheostomy site he was awake, breathing spontaneously only requiring cpap".The incident was reported to have occurred as the tracheostomy was being exchanged for a bigger size.The device was the "only conduit through the surgically created tracheostomy stoma".The patient was reported to have died after transfer to a care facility in the community.The physician is "unsure" of the cause of death.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Additional information: b5, b7, d11, e4.Corrections: a3, a5, a5b, b3, d- product identifier, d1, d4, h4, h6- patient codes.B3- date of event: (b)(6) 2019 d- product identifier: unknown, suspected to be g36401-c-cae-11.0-100-dlt-ef-st d4- rpn: unknown, suspected to be c-cae-11.0-100-dlt-ef-st, expiration date: unknown , udi: unknown.D11- concomitant products: size 7 portex tracheostomy tube; size 8 portex tracheostomy tube; size 8 adjustable flange tracheostomy tube (manufacturer unknown); manujet (manufacturer unknown); cook rapi-fit adapter; h4- manufacture date: unknown.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Investigation - evaluation: (b)(6) from (b)(6) informed cook on (b)(6) 2019 of an incident involving an unknown rpn.The device was most likely a cook airway exchange catheter ¿ extra-firm with soft tip [rpn: c-cae-11.0-100-dlt-ef-st].During a tracheostomy tube exchange procedure there was an incident with a cae through a tracheostomy exchange and then jet ventilation that lead the patient to be diagnosed with a severe hypoxic brain injury.The patient died a few weeks later and the cause of the death is unknown.A review of the instructions for use (ifu), manufacturing instructions (mi), and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify nonconforming product prior to distribution.A review of the design history files found that the suspected device is both safe and effective for its intended use.While the precise lot number was not provided by the user facility, cook was able to narrow down to 28 potential lots for the complaint device.Of those 28 lots, no non-conformances were revealed in their dhrs.Additionally, a database search found no other events associated with those 28 lots.There is no evidence suggesting that nonconforming product from the affected lot exists in house or in the field.In addition, this investigation found that there is no evidence that the device was not manufactured to specification.Cook also reviewed product labeling.The product¿s instructions for use [ifu], ¿cook airway exchange catheters with rapi-fittm adapters¿ provides the following information to the user related to the reported failure mode: device description: ¿the cook airway exchange catheter is a blunt-tipped radiopaque catheter with centimeter markings to facilitate placement.The catheter is supplied with a rapi-fit adapter (with either a 15mm connector or a luer lock connector), permitting use of ventilatory devices during exchange procedure.¿ intended use: -¿the cook airway exchange catheter is intended for uncomplicated, atraumatic endotracheal tube exchange.¿ warnings: ¿attention should be paid to insertion depth of catheter into patient¿s airway and correct tracheal position of replacement endotracheal tube.Markers on the cook airway exchange catheter refer to distance form tip of catheter.Catheter and endotracheal tube should not be advanced beyond the carina.¿ ¿to avoid barotrauma, ensure that the tip of the cae catheter is always above the carina, preferably 2-3cm.¿ potential adverse events: ¿barotrauma.¿ ¿perforation of the bronchi or lung parenchyma.¿ instructions for use for use of rapi-fittm adapter: ¿a ventilatory device may be used at any time during the endotracheal tube exchange procedure by utilizing the attached rapi-fit adapter.1.To attach rapi-fit adapter, position the adapter on catheter, then push the white collar forward and lock into position.Note: use of a high-pressure oxygen source should only be considered if the patient has sufficient egression of the insufflated gas volume.¿ instructions for use endotracheal tube exchange: ¿before advancing the cook airway exchange (cae) catheter into the endotracheal tube to be replaced, confirm correct endotracheal tube position.¿ ¿using the outer margin of the patient¿s mouth or nasal orifice as a landmark, note the marking on the endotracheal tube.¿ ¿advance the cae catheter, sideported end first, into the endotracheal tube to be replaced.¿ ¿caution: to avoid barotrauma, ensure that the tip of the cae catheter is always above the carina, preferably 2-3cm.¿ ¿maintaining position of the cae catheter, using patient¿s mouth or nasal orifice (depending on approach) as a landmark, advance the new endotracheal tube over the cae catheter and position it appropriately.¿ ¿confirm its position using standard methods (e.G., capnography, breath sounds and chest x-ray).¿ how supplied: ¿upon removal from the package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no product returned, and the results of the investigation, a definitive root cause was traced to the user's failure to follow instructions.The ifu states ¿the cook airway exchange catheter is intended for uncomplicated, atraumatic endotracheal tube exchange.¿ the device was not intended to be inserted through a tracheostomy tube.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional patient/event information has been received since the previous medwatch report was sent.

• Brand Name: COOK AIRWAY EXCHANGE CATHETER
• Type of Device: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9547482
• MDR Text Key: 173646115
• Report Number: 1820334-2020-00052
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 00827002107892
• UDI-Public: (01)00827002107892(17)220208(10)9509100
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2022
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death