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 Code Available (3191)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: unknown.(b)(4).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.The wire guide, guiding catheter and blue rhino dilator were returned for evaluation.The safety ridge of the catheter measured within the specified diameter.The inner diameter of the dilator tip also measured within specifications.Additionally, a document-based investigation evaluation was performed.It was concluded that there are sufficient controls in place to detect this failure mode prior to release.A review of the device history record for lot 8977135 found no nonconformances that could have contributed to this failure mode.It should be noted that there have been no other complaints reported for this lot number.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: instructions for use: 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 properly positioned at the safety ridge on the guiding catheter to prevent possible trauma to the posterior tracheal wall during introduction.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 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 a ciaglia blue rhino percutaneous tracheostomy introducer set with versa tube passed over the safety ridge of the white preloaded guiding catheter during a percutaneous tracheostomy procedure.It was noted that the, "tip was very soft so curved and went to mediastinum." it was later reported that neither bronchoscopy or other imaging were used during the procedure.To confirm placement of the needle in the trachea, a syringe with saline was connected to the needle, and as the user aspirated, air was observed.The wire was placed and maintained within the trachea as the 14fr dilator was being introduced, and a twisting motion was used to insert the introducer.The wire guide was still placed in the trachea when the 14fr dilator was removed.Even with the hydrophilic coating of the blue rhino activated, resistance was experienced when placing the device.A "little" bleeding occurred from the procedure, however, no additional surgical interventions were needed.The procedure was completed successfully.

• 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: 8908098
• Report Number: 1820334-2019-02043
• Device Sequence Number: 2731167
• Product Code: JOH
• UDI-Device Identifier: 00827002556515
• UDI-Public: (01)00827002556515(17)210713(10)8977135
• 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: 07/13/2021
• Device Model Number: N/A
• Device Catalogue Number: C-PTIS-350-HC-G-VT8
• Device Lot Number: 8977135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• 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: 67 YR
• Patient Weight: 80