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

Model Number N/A

Device Problems Difficult to Insert (1316); Device-Device Incompatibility (2919)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E3 - occupation: rrt g4 ¿ pma/510(k) #: k193133.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 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 or that a death or serious injury occurred; nor is it admission 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

It was reported that the white guiding catheter/blue rhino dilator assembly from a blue rhino g2-multi percutaneous tracheostomy introducer tray was difficult to advance.The physician confirmed that the proximal end of the blue rhino dilator was positioned at the single positioning mark on the white guiding catheter.During placement of the device with bronchoscopic guidance, the blue rhino advanced beyond the safety ridge of the white guiding catheter, and the wire guide was no longer leading the blue rhino/guiding catheter assembly.As a result, the patient experienced a posterior tracheal wall injury.Additional information regarding the event and patient outcome has been requested but is currently unavailable.It was noted that ultrasound was not used to evaluate the patient's neck prior to the procedure.

Manufacturer Narrative

Investigation ¿ evaluation: it was reported by a representative of (b)(6) hospital that on an unknown date the blue rhino dilator in a blue rhino g2-multi percutaneous tracheostomy introducer tray (rpn: c-ptisy-100-hc-g-na; lot#: unknown) advanced over the safety ridge of the white guiding catheter.The physician stated that ultrasound was not used to evaluate the patient's neck prior to the procedure.The physician confirmed that the proximal end of the blue rhino dilator was positioned at the single positioning mark on the white guiding catheter.The physician confirmed the dilator had advanced over the safety ridge of the guiding catheter, and the wire guide was no longer leading the blue rhino/guiding catheter assembly.As a result, posterior tracheal wall injury occurred.No other adverse events were reported due to this occurrence.Reviews of the complaint history, quality control, manufacturing instructions (mi), and instructions for use (ifu) were conducted during the investigation.The complaint device was not returned.However, the customer did return many devices from different lots.Twenty-one of the returned devices were tested and the safety ridge and blue rhino were within specification.Due to this complaint device not being returned, cook cannot confirm the device was manufactured out of 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 device history record (dhr) was unable to be completed due to a lack of lot information.An expanded sales search to the customer was unable to identify the complaint lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The lot number was not provided; therefore, the most recent ifu packaged with the device was reviewed.The ifu contains the following in relation to the reported failure mode: "contraindications: patients with enlarged thyroids; nonpalpable cricoid cartilage; previous surgery at the tracheostomy site (e.G.Thyroidectomy).Potnetial adverse events: perforation of the trachea; failed tracheostomy tube placement; hypoxia.Tracheostomy procedure: palpate the landmark structures (thyroid notch, cricoid cartilage) to ascertain proper location for tracheostomy tube placement.Access and ultimately tube placement is ideally made at the level between the first and second tracheal cartilages or between the second d third tracheal cartilages whenever feasible.Make a 1.5-2.0 cm skin incision (vertical or horizontal) at the chosen insertion site.Note: an adequate skin incision and blunt dissection of the subcutaneous tissue can minimize the need for excessive force¿ activate the hydrophilic coating by immersing the distal end of the blue rhino g2-multi dilator in sterile water or saline.Advance the blue rhino g2-multi dilator and the guiding catheter as a unit over the wire guide, while maintaining wire guide position.Note: align the proximal end of the guiding catheter at the mark on the proximal portion of the wire guide.This will ensure that the distal end of the guiding catheter is properly positioned back on the wire guide, preventing possible trauma to the posterior tracheal wall during subsequent manipulations.Note: bronchoscopic guidance may also prevent possible trauma to the posterior tracheal wall.15.Begin to dilate the tracheal access site by advancing the guiding catheter and blue rhino g2-multi dilator into the trachea.To properly align the dilator on the wire guide/guiding catheter assembly, position the proximal end of the dilator at the single positioning mark on the guiding catheter.This will ensure that the distal tip of the dilator is properly positioned at the safety ridge on the guiding catheter to prevent possible trauma to the posterior tracheal wall during introduction.16.Advance and pull back the dilating assembly several times to effectively dilate the tracheal access site.Note: the wire guide must always lead the dilatory and the guiding catheter assembly to prevent possible trauma to the posterior tracheal wall during dilation.Care should be taken to keep the guiding catheter assembly properly aligned with the mark on the proximal portion of the wire guide.This will ensure that the tip of the guiding catheter assembly does not advance beyond the distal tip of the wire guide within the trachea¿" based on the available information, no product returned, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to the event.It is possible the patient had torturous anatomy and caused the need for excessive force.Excessive force could have caused the blue rhino to advance over the catheter¿s bump.It¿s also possible the rhino or the guiding catheter was damaged.However, none of these possibilities can be confirmed without additional information and/or physical examination of the complaint device.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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 or that a death or serious injury occurred; nor is it admission 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: BLUE RHINO G2-MULTI PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
• Type of Device: 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: 16994712
• MDR Text Key: 315880628
• Report Number: 1820334-2023-00649
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• 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-PTISY-100-HC-G-NA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2023
• 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