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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Hypoventilation (1916); Foreign Body In Patient (2687)

Event Date 04/01/2008

Event Type  Injury  

Manufacturer Narrative

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.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.

Event Description

The following case report, regarding a 60 year old male patient requiring airway management after a cuff leak was identified in an in-situ endotracheal tube (ett), came from the article: chen, i.C.J., huang, c.S., chen, p.T., hsieh, c.C., hsu, h.S., wu, y.C., & hsu, w.H.(2008).A rare iatrogenic bronchial foreign body detected by routine bronchoscopy after percutaneous tracheostomy: https//doi.Org/10.29806/tm.200804.0012.Case report: "a 60-year-old man had hemangioblastoma of the left cerebellum.He underwent craniectomy and removal of the cerebellar tumor.Postoperative weakness of his right extremities and the condition of choking easily, developed thereafter.His neurosurgeons were aware of the lower cranial nerve palsy.Striders and diffuse rhonchi worsened, and he required frequent suctioning for thick excessive secretion.He was reintubated 3 months after the operation and placed on mechanical ventilation during the prolonged postoperative hospital stay.A significant cuff leak occurring on insertion of the endotracheal tube necessitated an immediate tube change using a 14-f, 83-cm, cook airway exchange catheter, as well as a rapi-fit connector to ventilate the patient with jet ventilation during the exchange.The postintubation chest radiograph (figure 1a) showed marked collapse of the middle and lower lobes of the right lung, with a deep sulcus sign lateral to the right hemidiaphragm.The upper lobe of the right lung seemed to remain expanded.The findings were consistent with localized pneumothorax.We used chest tube drainage with a 16 french pigtail catheter, (neither the application of the airway exchange catheter nor the plastic tube that had disappeared from it was made known) (figure 2d).The chest radiograph obtained later that day (figure 1b) showed reexpansion of the right lung and resolution of the localized pneumothorax.The pigtail catheter was removed 4 days later, and no more pneumothorax occurred.A series of chest radiographs, as in figures 1a and 1b, failed to demonstrate the foreign body in the bronchus intermedius we performed pdt using a guide wire dilating forceps under fiberoptic bronchoscopic guidance due to neurogenic alveolar hypoventilation 11 days after reintubation.When we performed routine fiberoptic bronchoscopy after inserting the tracheostomy tube, the previously dislodged plastic tube was detected unexpectedly in the bronchus intermedius (figures 2a and 2b).We extracted this endobronchial foreign body smoothly by using fiberoptic bronchoscopic alligator forceps (figure 2c).Shortly afterwards, we confirmed that the extracted plastic tube was the cap of the airway exchange catheter used to connect to the connector (figure 2d).The patient was weaned off mechanical ventilation successfully 18 days after pdt, and could self-expectorate favorably via an uncuffed tracheostomy tube at home during a 10-month follow-up." authors note : "the possible cause of the foreign body in our case could be that the airway exchange catheter was used upside down." no other adverse effects were reported for this incident.

Event Description

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

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation cook became aware on 14oct2022 of a journal article by dr.Isaac chun-jen chen of vgh taipei taiwan (taiwan) concerning a cook airway exchange catheter (rpn: c-cae-14.0-83; lot unknown).The 60-year-old male patient was reintubated 01aug2008, three months after a procedure.He was placed on mechanical ventilation during his prolonged postoperative hospital stay.A significant cuff leak occurring on insertion of the endotracheal tube required an immediate tube change using cook¿s c-cae-14.0-83 exchange catheter, as well as a rapi-fit connector to ventilate the patient with jet ventilation during the exchange.The customer stated that part of the rapi-fit separated and migrated to the patient¿s lung.The foreign body was extracted smoothly by using fiberoptic bronchoscopic alligator forceps.The patient was weaned off mechanical ventilation successfully 18 days after pdt and could self-expectorate favorably via an uncuffed tracheostomy tube at home during a 10-month follow-up.Reviews of the complaint history, instructions for use (ifu), and quality control procedures of the device were 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.In response to this incident, cook completed a review of the product device master record (dmr) and process steps were identified to ensure non-conforming material does not leave house.A review of the device history record (dhr) was unable to be completed due to a lack of lot information in the journal article.A sales report was reviewed; however, it was not possible to determine a possible lot number.Based on the device master record, no lot number for a device history record, and with no product return, cook was unable to determine the product out of specification.Cook was not able to determine evidence of any non-conforming material in house or in the field.Cook also reviewed product labeling.This product is supplied with an instructions for use (ifu) pamphlet, c_t_cae_rev6.In the instructions for use section, it states: 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.In the how supplied section it states: upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, no returned device, and the results of the investigation, the main cause for this event could not be established.It is possible that the customer used too much force on the adapter causing the white silicone insert to separate from the adapter.There is also a possibility that the white silicone insert was damaged before use and finally broke off the adapter when the procedure began.Another possibility is the device and/or white silicone insert was out of specification, however, without product return this cannot be confirmed.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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.

• Brand Name: COOK AIRWAY EXCHANGE CATHETER
• Type of Device: LRC CHANGER, TUBE, ENDOTRACHEAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15628122
• MDR Text Key: 301980369
• Report Number: 1820334-2022-01639
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-CAE-14.0-83
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male