MAUDE Adverse Event Report: COOK INC MELKER EMERGENCY CUFFED CRICOTHYROTOMY CATHETER SET; BWC NEEDLE, EMERGENCY AIRWAY

Model Number N/A

Device Problem Break (1069)

Patient Problems Cardiac Arrest (1762); Foreign Body In Patient (2687); Respiratory Insufficiency (4462)

Event Date 09/28/2021

Event Type  Injury  

Event Description

It was reported that the wire guide of a melker emergency cuffed cricothyrotomy catheter set sheared off inside of the patient, requiring surgical retrieval.On (b)(6) 2021, a (b)(6) male patient presented to the emergency department with complaint of shortness of breath.Intubation with a video laryngoscope was attempted but was unsuccessful due to laryngeal swelling.An emergent cricothyrotomy was performed.Then, the patient underwent a open tracheostomy due to persistent hypercarbia.The patient recovered and was discharged from the facility with the tracheostomy, but returned on (b)(6) 2021 for decannulation.The patient presented to another institution on (b)(6) 2021 in respiratory distress requiring intubation post cardiac arrest with successful return to spontaneous circulation (rosc).The first chest x-ray following intubation revealed a "linear metallic object in his airway that very much appeared to be a segment of a guidewire that had sheared off abruptly." the segment of wire was then removed by the ear, nose, and throat (ent)/radiology service(s).Due to the patient's co-morbidities, it is unclear if the retained wire segment contributed to the patient's respiratory distress.It was reported that after the emergent cricothyrotomy, "the wire was coiled", but no shearing was noted.The device was discarded immediately following the procedure.Additional information regarding event and patient details has been requested, but is currently unavailable.

Manufacturer Narrative

Additional common device name: joh tube tracheostomy and tube cuff.Additional pro code: joh.Occupation: senior distribution operations coordinator.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation it was reported by (b)(6) of (b(6) hospital (united states) on (b)(6) 2021 that the wire guide in a melker emergency cuffed cricothyrotomy catheter set (rpn: c-tccsb-500, possible lot #s - 13688006 and 13734770) separated and was retained in a patient.A 59-year-old male with history of laryngeal cancer, chronic obstructive pulmonary disease (copd), chronic lymphocytic leukemia (cll), and a previous tracheostomy presented to the emergency department with shortness of breath.Intubation with a video laryngoscope was attempted but was unsuccessful due to throat (laryngeal) swelling; therefore, an emergent cricothyrotomy was performed with the melker set.The patient then underwent an open tracheostomy due to persistent elevation of carbon dioxide levels (hypercarbia).The patient recovered and was discharged from the hospital.He returned on (b)(6) 2021 to have the tracheostomy removed (decannulation).On (b)(6) 2021, the patient presented to another institution in respiratory distress requiring intubation, following cardiac arrest with successful return of spontaneous circulation (rosc).A chest x-ray post intubation revealed a ¿linear metallic object in his airway that very much appeared to be a segment of a guidewire that had sheared off abruptly¿.The fragment was then removed by ent/radiology.No other adverse events were reported due to this occurrence.Reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, 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.Additionally, a document-based investigation evaluation was performed.Cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook reviewed the device history record (dhr) for both possible lot numbers provided by the customer.Lot# 13688006 and its subassembly lots revealed no related non-conformances or additional complaints.Lot# 13734770 had one unrelated non-conformance.Ic13628744 had two non-conformances with the first being unrelated.The second non-conformance could be related to this failure.This non-conformance is for where the wire was broken, and the product was scrapped.Sa13614770 did not have any non-conformances.There are no additional complaints associated with this possible lot.Based on the dmr, dhr, and no device return, cook was not able to determine the product manufactured out of specification.There is no evidence of 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_tccs_rev8.In the warnings section it states: consideration should be given to the following medical and anatomic conditions: distorted anatomy, subcutaneous abscess, hematoma, post-operative scarring/radiation, and coagulopathies or systemic thrombolytic therapy.In the instructions for use section, it states: 5) advance the soft, flexible end of the wire guide through the catheter or needle and into the airway several centimeters.6) remove the catheter or needle, leaving the wire guide in place.8) advance the airway catheter/dilator assembly over the wire guide until the proximal stiff end of the wire guide is completely through and visible at the handle end of the dilator.It is important to continually visualize the proximal end of the wire guide during the airway insertion procedure to prevent its inadvertent loss into the trachea.9) maintaining wire guide position, continue to advance the airway catheter/dilator assembly over the wire guide with reciprocating motion completely into the trachea.(fig.4) take care not to advance the tip of the dilator beyond the tip of the wire guide within the trachea.10) remove the wire guide and dilator simultaneously.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 product and the results of the investigation, it was determined the cause of this event could have been related to device failure or unintended user error.A definitive cause for this failure could not be established.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 the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: MELKER EMERGENCY CUFFED CRICOTHYROTOMY CATHETER SET
• Type of Device: BWC NEEDLE, EMERGENCY AIRWAY
• 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: 12913335
• MDR Text Key: 286441024
• Report Number: 1820334-2021-02614
• Device Sequence Number: 1
• Product Code: BWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• 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-TCCSB-500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2022
• 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: 59 YR
• Patient Sex: Male