MAUDE Adverse Event Report: COOK INC BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY; JOH TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter occupation: patient care manager.Pma/510k: k193133.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
A patient of unspecified gender and age underwent a tracheostomy procedure where a cook blue rhino g1-multi percutaneous tracheostomy introducer was used.The patient did not have any anatomical anomalies that would have made the procedure difficult to perform.Bronchoscope guidance was used during placement.The wire guide was inserted through the needle.There was no difficulty advancing the wire guide into the trachea.The wire guide was not withdrawn at the same time the dilator and catheter were removed.The guide wire was reported to have "looped back on itself and was kinking inside the trachea." the procedure was completed, but the use of a bronchoscope with forceps was required to remove the wire.An esophagogastroduodenoscopy (egd) examination was required to rule out esophageal injury after the removal of the guide wire.The event did not prolong the patient's hospitalization.No other adverse effects to the patient were reported.
Additional Manufacturer Narrative
Upon further investigation, this event is not reportable.There is no information confirming device malfunction or serious injury.It was determined that removing the kinked wire guide with the assistance of bronchoscope and forceps does not constitute intervention to preclude permanent impairment or death.A review of risk documentation does not indicate that this event is likely to cause serious injury if it were to reoccur.A detailed search of complaint history has revealed no previous events involving the failure mode "kinks" that has led to a serious injury.As there are no recorded incidences of serious injury due to the complaint event, and it is not likely that serious injury would result if the event were to recur, per 21cfr part 803.50 the complaint event is considered not reportable.
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: BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: 14642308
• Report Number: 1820334-2022-01018
• Device Sequence Number: 5720349
• Product Code: JOH
• UDI-Device Identifier: 00827002577169
• UDI-Public: (01)00827002577169(17)230501(10)14345680
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: N/A
• Device Catalogue Number: C-PTISY-100-HC-G-NA-FLEX7.5
• Device Lot Number: 14345680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown