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

Model Number	N/A
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Event is still under investigation at this time.
Event or Problem Description
The initial information stated that the white cannula is defective as it would not allow the guide wire to pass inside, thus the blue rhino would not advance.Update 05jul2016 - information was provided that the user required use of another blue rhino device.The patient required a longer anaesthetic than necessary and there was a potential for injury to the trachea.The staff surgeon, said it was very dangerous - and a flexible bronch was used to check for injuries.Once the new device was utilized, the procedure was completed as planned.
Additional Manufacturer Narrative
(b)(4).Investigation / evaluation: during the course of investigation.A dimensional verification, functional test, and a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions (mi), quality control (qc), and a visual inspection of the returned used product was conducted.The device is packaged with an instructions for use (ifu); which gives device description and intended use as well as appropriate warnings, precautions and contraindications associated with the device as well as instructions for placement and proper use of the device.During inspection of the returned product, the wire was inserted into the tracheostomy catheter.It was noted a permanent 90 degree bend in the wire noted at 14.5 cm proximal to the distal tip.There were also two smaller kinks at 17 cm and 18 cm respectively located proximal to the distal tip.In spite of the kinks and bend, the wireguide was able to be inserted and moved inside the tracheostomy catheter, but with slight difficulty.The noted bend and kinks in the wire guide likely contributed to the customer's difficulty in placing the wire guide inside the tracheostomy catheter.It is unclear from the description of the event and from the examination of the returned device as to how the wire guide was kinked.As the ifu provided with the device cautions against using force and in several locations instructs the clinician to use care in the placement of the device it is likely that once the wire guide was kinked and bent, the force required to advance the catheter seemed too high to the clinician and the clinician then chose to use a replacement device to complete the procedure.Per quality control specification, there is confirmation that the correct size tubing has been used.The surface of the catheter is also checked to be smooth, free of dirt and damage.And that the catheters have correct end hole size.There is also a verification of a smooth transition between the catheter and wire guide checker.A search of the complaint database shows this to be the only complaint associated with this lot number.Based on the information provided and the results of our investigation, we are unable to determine with certainty the root cause of the reported difficulty.However, we have notified the appropriate internal personnel and will continue to monitor for similar events.Per the conclusion of the quality engineering risk assessment (qera), additional risk reduction is not required.
Event or Problem Description
The initial information stated that the white cannula is defective as it would not allow the guide wire to pass inside, thus the blue rhino would not advance.Update 05jul2016 - information was provided that the user required use of another blue rhino device.The patient required a longer anaesthetic than necessary and there was a potential for injury to the trachea.The staff surgeon, said it was very dangerous - and a flexible bronch was used to check for injuries.Once the new device was utilized, the procedure was completed as planned.

• Brand Name: CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5785816
• Report Number: 1820334-2016-00669
• Device Sequence Number: 260018
• Product Code: JOH
• UDI-Device Identifier: 00827002531734
• UDI-Public: (01)00827002531734(17)190222(10)6730260
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133597
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-PTIS-100-HC-G
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2016
• Supplement Report FDA Received Date: 09/06/2016
• 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: Other