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

Catalog Number C-TCCS-350

Device Problem Break (1069)

Patient Problems Death (1802); Patient Problem/Medical Problem (2688)

Event Date 07/20/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).Preliminary investigation -evaluation: the complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.The device is shipped with an instruction for use (ifu) that describes the intended use; specific items are addressed such as: ".Warnings:.Consideration should be given to the following medical and anatomic conditions: distorted anatomy.Subcutaneous abscess.Hematoma.Post-operative scarring/radiation.Coagulopathies or systemic thrombolytic therapy.Instructions for use.Advance the soft, flexible end of the wire guide through the catheter or needle and into the airway several centimeters.Remove the catheter or needle, leaving the wire guide in place.Advance the handled dilator, tapered end first, into the connector end of the airway catheter until the handle stops against the connector.Note: this step may be performed prior to beginning the procedure.Use of lubrication on the surface of the dilator may enhance fit and placement of the airway catheter.Advance the airway catheter/dilator assembly over the wire guide until the proximal stiff end of the wire guide is completed 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.Maintaining wire guide position, continue to advance the airway catheter/dilator assembly over the wire guide with a reciprocation motion completely into the trachea.Take care not to advance the tip pf the dilator beyond the tip of the wire guide within the trachea.How supplied.Upon removal from 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 could not be determined.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

A letter was received on (b)(6) 2018 from (b)(6) hospital (b)(6) informing the manufacturer of an incident that occurred on (b)(6) 2018.It was reported a patient underwent a cricothyrotomy procedure performed by a doctor from (b)(6) team in an emergency vehicle.The patient was in cardiopulmonary arrest due to a quincke edema for 15-minutes prior to the initiation of procedure.The patient passed not because of a failed procedure but because vitals were compromised from cardiopulmonary arrest.A (b)(6) emergency cricothyrotomy catheter set was the.Device utilized in the cricothyrotomy.As reported, the guide for mounting the cannula broke when removing the dilator.The cricothyroidotomy was unable to be performed relate to edema.When the edema regressed, the patient was intubated by oral trachea route.Additional information has been requested including if an autopsy report is available, additional sequence of event details, the length of time before oral tracheal intubation was achieved, and medications and other devices used during this event.However, the reporter stated that the patient death was not linked with use of the device.Therefore, they would not communicate any more data than was previously reported.

Manufacturer Narrative

Blank fields on this form indicate the information has previously been reported, is unknown or is unavailable.Investigation evaluation: the preliminary document-based investigation reported on 20-aug-2018 remains unchanged.There are no additional complaints for the reported lot number and no non-conformances were found that would cause or contribute to this failure.The device was not available for return.The pharmacist confirmed, as stated in the initial report, the patient death was not linked to the device failure.It was determined the patient expired not because of the cricothyrotomy procedure fail but because the patient was already in cardiopulmonary arrest for 15 minutes.A review of risk controls states a potential cause of failure to be "wire guide does not withstand forces during manipulation or withdrawal".The complaint investigation established possible causes for the wire separation including: failure include difficult patient anatomy, device use, use of excessive force, manufacturing errors, etc.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required at this time.Monitoring will continue to be performed 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.

• Brand Name: MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET
• Type of Device: BWC NEEDLE, EMERGENCY AIRWAY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7799908
• MDR Text Key: 117689647
• Report Number: 1820334-2018-02219
• Device Sequence Number: 1
• Product Code: BWC
• UDI-Device Identifier: 00827002062467
• UDI-Public: (01)00827002062467(17)200617(10)7999072
• Combination Product (y/n): N
• PMA/PMN Number: K013916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2020
• Device Catalogue Number: C-TCCS-350
• Device Lot Number: 7999072
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASKU
• Patient Outcome(s): Death; Other
• Patient Age: 66 YR
• Patient Weight: 85