MAUDE Adverse Event Report: COOK INC MELKER EMERGENCY UNIVERSAL CRICOTHYROTOMY CATHETER SET; JOH TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	G32193
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Swelling (2091); No Code Available (3191)
Date of Event	07/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: (b)(6) 2020.Additional common name: bwc needle, emergency airway.Additional product code: bwc.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.(b)(4).
Event or Problem Description
It was reported that the balloon of a melker emergency universal cricothyrotomy catheter set would not inflate.The device was placed during an emergent cricothyrotomy for the patient's epiglottis in the user facility's emergency department sometime in july 2020.Following placement, the patient was transferred to the user facility's icu where he later experienced hypercarbia and worsening tidal volumes.Vent adjustments were unsuccessfully made.The trach balloon was checked.An attempt was made to try to close the leak from the neck but was also unsuccessful.Afterwards, it was realized that the leak was coming from the patient's mouth rather than their neck.The patient was intubated and the device was removed.The balloon was tested and found to be not inflating.Additional information regarding the patient, device, and event has been requested but is currently unavailable.
Additional Manufacturer Narrative
Additional information: b2, b5, h6 - patient code.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 or Problem Description
Additional information was received on 19aug2020.No unintended section of the device remained in the patient's body.The patient was hospitalized but it is unknown if their hospitalization was prolonged.This occurrence caused additional swelling to the patient and required intubation.The component was placed in the trachea.There was difficulty experienced inserting this device as the balloon was faulty.The tube was immediately removed when placed and the patient required emergent intubation.The patient has since been discharged from the hospital.It is unknown if an initial inflation check was performed prior to device placement.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation it was reported in a medwatch form completed by somerville hospital in massachusetts that the balloon of a melker emergency universal cricothyrotomy catheter would not inflate.The 65-year-old white male patient was first seen on (b)(6) 2020 in the user facility's emergency department (ed) where the device was placed and used.Afterwards, the patient was admitted to the intensive care unit (icu).Upon arrival to the icu, the patient had worsening hypercarbia and tidal volumes while on the ventilator despite adjustments to the ventilator and checking the cricothyrotomy catheter/tube balloon.An unsuccessful attempt was made to close the leak from the neck.It was then discovered that the leak was from the mouth of the patient rather than the neck.It was then discovered that the device's balloon would not inflate.As a result, the patient was intubated causing additional swelling and the device was removed.The patient remained in the hospital.A review of the complaint history, device history record (dhr), instructions for use (ifu) and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One used melker emergency universal cricothyrotomy catheter set was returned to cook for evaluation.Upon visual inspection, the balloon was noted to be torn.A ventilator adapter was attached to the catheter/tube.Cook has concluded that the device was manufactured to specification.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 dhrs for the reported device lot (9601065) and the related catheter component lots revealed no recorded non-conformances relevant to the failure mode.A database search identified no other events associated with the reported device lot.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 have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The cricothyrotomy catheter set was supplied with an ifu which includes the following in relation to the failure mode: ¿warnings -the melker universal cricothyrotomy catheter set is not specifically designed for pediatric applications.Use with pediatric patients should be determined by attending physician -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 seldinger techniqe 11.If pacing a cuffed airway catheter, inflate the cuff with air using a syringe.(fig 7) note: an 8-10ml volume in the cuff will yield a cuff diameter of 22-29mm.The inflation and deflation procedure is at the discretion of the physician.Warning: inflation of the cuff with more than 20 ml is not recommended.Surgical technique 9.Inflate the cuff using a syringe; 8-10ml volume in the cuff will yield a cuff diameter of 22-29mm.The inflation and deflation procedure is at the discretion of the physician warning: inflation of the cuff with more than 20 ml is not recommended¿ based on the information provided, inspection of the returned device, and the results of the investigation, a potential root cause for this event has been traced to component failure.A clinical analysis of this event concluded that the most probable cause for this event is related to the medical procedure.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 or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: MELKER EMERGENCY UNIVERSAL CRICOTHYROTOMY CATHETER SET
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10421492
• Report Number: 1820334-2020-01507
• Device Sequence Number: 14188786
• Product Code: JOH
• UDI-Device Identifier: 00827002321939
• UDI-Public: (01)00827002321939(17)220131(10)9601065
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K010016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: G32193
• Device Catalogue Number: C-TCCSB-500-UNI
• Device Lot Number: 9601065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 08/19/2020; 12/03/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 09/08/2020; 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR