MAUDE Adverse Event Report: COOK INC CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH VERSA TUBE; JOH TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	N/A
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.Investigation - evaluation.A review of documentation including the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control and specifications, as well as a visual inspection and dimensional verification of the returned device was conducted during the investigation.A used dilator and catheter were returned for evaluation.The inner diameter at the distal end of the dilator was measured and was found to be within specifications.The safety ridge on the catheter was found to be out of round, likely as a result of passing through the distal tip of the dilator.Measurements were taken at different points of the safety ridge and were all found to be within specification.No other damage to the device was noted.Additionally, a document-based investigation evaluation was performed.It was concluded that there are adequate controls in place to ensure the device is manufactured to specifications.A review of the device history record for lot 8993907 found no nonconformances that could have contributed to this failure mode.It should be noted that there were no other complaints reported for this lot number.There is no evidence to suggest that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: bronchoscopic guidance is strongly recommended during placement of this device to reduce the likelihood of paratracheal insertion and to determine the intratracheal position of the needle, wire guide, dilators, and tracheostomy tube.Maintain safety positioning marks of the wire guide, guiding catheter, and dilator during dilating procedure to prevent trauma to posterior wall of the trachea.Tracheostomy procedure: "2.After introducing local anesthesia, make a 1.5-2.0 cm skin incision (vertical or horizontal) at the chosen insertion site." "13.Activate the hydrophilic coating by immersing the distal end of the ciaglia blue rhino g2 advanced dilator in sterile water or saline.14.Advance the ciaglia blue rhino g2 advanced 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 hat 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.15.Begin to dilate the tracheal access site by advancing the guiding catheter and ciaglia blue rhino g2 advanced 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.While maintaining the visual reference points and positioning relationships of the wire guide, guiding catheter, and dilator, advance them as a unit to the skin level mark on the ciaglia blue rhino g2 advanced dilator.Note: proper positioning and alignment may help minimize complications." based on the information provided, examination of the returned product and the results of our investigation, the likely cause can be traced to the user and an unintended use error.The area representative reported that they observed the physicians performing this procedure and noted that they were having difficulties and not following the ifu, including not creating an incision with a scalpel prior to needle introduction.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.We will continue to monitor for similar complaints.
Event or Problem Description
It was reported that the dilator of the ciaglia blue rhino percutaneous tracheostomy introducer set with versa tube passed through the safety ridge of the white preloading guiding catheter during a tracheostomy procedure.In the user's opinion the, "rhino dilator is too soft." it was later reported that the ifu was referenced during the procedure.A twisting motion was used to insert the 14fr introducer, and a little resistance was experienced during placement.The hydrophilic coating was activated on the blue rhino.It was reported by the sales representative that the procedure was not performed according to the instructions for use (ifu).It was noted that the procedure began with a puncture without a skin incision and no pre-tracheal dissection.A total of seven puncture attempts were made.A fiber scope was also not used during the procedure.The procedure was completed successfully.As reported, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WITH VERSA TUBE
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8907995
• Report Number: 1820334-2019-02042
• Device Sequence Number: 19515704
• Product Code: JOH
• UDI-Device Identifier: 00827002556515
• UDI-Public: (01)00827002556515(17)210716(10)8993907
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K133597
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/16/2021
• Device Model Number: N/A
• Device Catalogue Number: C-PTIS-350-HC-G-VT8
• Device Lot Number: 8993907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 70