MAUDE Adverse Event Report: COOK INC COOK DOUBLE LUMEN EXTRA FIRM SOFT TIPPED AIRWAY EXCHANGE CATHETER; LRC CHANGER, TUBE, ENDOTRACHEAL

Model Number N/A

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510(k) #: exempt.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that a cook double lumen extra firm soft tipped airway exchange catheter ruptured during an endotracheal tube exchange.Although the user did not apply strong force, the catheter suddenly ruptured during advancement into an endotracheal tube from another manufacturer.Following the rupture, the airway exchange catheter was removed from the endotracheal tube.The separated segment was able to be grasped with fingers and was subsequently removed.A new airway exchange catheter was opened and used to complete the procedure successfully.Lubricant was used to aid in the exchange.The patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: it was reported by (b)(6) medical center, japan that a cook double lumen extra firm soft tipped airway exchange catheter (rpn: c-cae-11.0-100-dlt-ef-st; lot: 13892843) separated.The airway exchange catheter (aec) was required by an unknown patient for endotracheal tube (ett) exchange.During the exchange, the user advanced the aec without ¿strong force¿ into the ett (medtronic taperguard, rpn and lot unknown).At this time, the user discovered that the aec had separated, so it was removed.The separated component was then removed by the user grasping it with their fingers.A new aec was obtained to successfully complete the ett exchange.It was noted that lubricant was utilized to aid the exchange.No adverse effects to the patient were reported.A review of the documentation including the complaint history, device history record, instructions for use (ifu) and quality control, as well as a visual inspection of the returned device was conducted during the investigation.One device without packaging was returned for evaluation.The catheter was noted to be in two pieces, with the point of separation having a stretched appearance.Additionally, 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 this failure mode prior to distribution.A review of the device history record (dhr) for lot 13892843 found no related nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with this lot number.As there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information related to the reported failure mode: for use in replacement of double-lumen endotracheal tubes or endotracheal tubes whose inner diameter (id) is 4mm or larger.Warnings: -ensure proper sizing of the cook airway exchange catheter within a double-lumen endotracheal tube.Failure to so may cause small fragments to be shave off during removal of the cook airway exchange catheter.Based on the information provided, examination of the returned product and the results of our investigation, a definitive cause for the failure could not be established.Patient anatomy, user technique, device selection or device failure could not be ruled out as a possible cause for this event.The appropriate personnel have been notified.Per the risk assessment no further action is required.We will continue to monitor for similar complaints.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 information regarding patient and/or event details has been received since the previous medwatch report was sent.

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 unknown, unavailable, and unchanged.Correction: upon further review, it was determined this event does not meet the criteria for a serious injury.Further discussion with regulatory reporting and clinical specialists determined that the physician was able to grasp the catheter and remove it without removing the endotracheal tube ("only the cae catheter was removed"), does not constitute medical intervention to preclude permanent impairment or death for this event.The secure airway was maintained during the product malfunction.Therefore, this event is no longer considered a serious injury per 21 cfr part 803.3.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 DOUBLE LUMEN EXTRA FIRM SOFT TIPPED 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: 12452181
• MDR Text Key: 270799023
• Report Number: 1820334-2021-02126
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 10827002364018
• UDI-Public: (01)10827002364018(17)240414(10)13892843
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2024
• Device Model Number: N/A
• Device Catalogue Number: C-CAE-11.0-100-DLT-EF-ST
• Device Lot Number: 13892843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 09/10/2021
• Supplement Dates Manufacturer Received: 11/04/2021; 12/17/2021
• Supplement Dates FDA Received: 11/30/2021; 01/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• 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
• Treatment: MEDTRONIC TAPERGUARD TRACHEAL TUBE; MEDTRONIC TAPERGUARD TRACHEAL TUBE
• Patient Outcome(s): Required Intervention