MAUDE Adverse Event Report: COOK INC CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WITH SHILEY; 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	01/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that while using a ciaglia blue rhino percutaneous tracheostomy introducer tray with shiley, the safety ridge on the white wire advanced through the dilator.The device was being used by the endoscopy team.While using the device, the physician stated that the "bulb on the white wire advanced through the dilator." the endoscopy team stopped the physician due to potential perforation.Another percutaneous tracheostomy tray kit was obtained because the physician felt that he had to begin the procedure with a new device when the bulb on the white wire advanced through the dilator.While using the second kit, the staff recognized the issue with the bulb and dilator again.The staff was aware of the potential so they caught it when it occurred.The tract was dilated with the 14fr dilator.The procedure was completed successfully.No adverse effects on the patient due to this occurrence were reported.
Event or Problem Description
No new event description information to report at this time.
Additional Manufacturer Narrative
Investigation - evaluation.A review of the complaint history, device history record, specifications, as well as a visual inspection and dimensional verification of the returned device was conducted during the investigation.One blue dilator with a wire guide and guiding catheter inserted was returned for evaluation.Biological matter was present along the surface, with no other surface damage noted.The dilator was able to pass over the safety ridge fairly easily.All dimensions deemed relevant to the reported failure mode were analyzed and it was determined that the device was manufactured out of specification.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record found four nonconformances relevant to the failure mode in the main lot 9278510, dilator lot ic9107174 and two guiding catheter lots ic9141493 and ic9112214.A total of 5 devices were scrapped for a bad dilator tip, 30 devices were scrapped for bad bumps and another 3 devices were scrapped for the safety ridge being too small in the guiding catheter.Due to all nonconforming products being scrapped and all devices going through a 100% inspection for nonconformances, it was concluded that there is no evidence of nonconforming product from these lots in house.However, due to two products failing on this lot, there is potential for nonconforming product to be out in the field.It should be noted that there have been no other complaints reported from the field for lot 9278510.The instructions for use (ifu), provides the following information to the user related to the reported warnings ".Exercise care to ensure that the components used in each step are properly positioned within 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.3.If desired, use a curved mosquito clap to gently dissect vertically and transversely down to the anterior tracheal wall.With a fingertip, dissect the front of the trachea, in the midline, free of any tissues and identify the cricoid cartilage.Note: an adequate skin incision and blunt dissection of the subcutaneous tissue can minimize the need for excessive force and torque throughout the procedure.Excessive force and rotation may lead to long-term complications (e.G., stenosis)¿ 11.Maintaining the wire guide's position at the skin level mark, dilate the initial tracheal access site by advancing the short, 14 french introducer dilator over the wire guide with a slight twisting motion." how supplied ".Upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, examination of the returned product and the results of our investigation, a definitive root cause can be traced to a manufacturing and quality deficiency.Appropriate measures have been taken to address this failure mode.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified and we will continue to monitor for similar complaints.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, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY WITH SHILEY
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8536928
• Report Number: 1820334-2019-00835
• Device Sequence Number: 1744439
• Product Code: JOH
• UDI-Device Identifier: 00827002125650
• UDI-Public: (01)00827002125650(17)200901(10)9278510
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K133597
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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: 09/01/2020
• Device Model Number: N/A
• Device Catalogue Number: C-PTISY-100-HC-PERC8
• Device Lot Number: 9278510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 109