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 Information (3190)
Date of Event	12/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 the cannula of a ciaglia blue rhino percutaneous tracheostomy introducer set does not fit over the wire guide.Additional information regarding the patient, device, and event has been requested but is currently unavailable.
Event or Problem Description
Additional information was provided on 13jan2021: it was reported that the cook guidewire could only be placed in the trachea cannula with extreme force.This resulted in delayed placement of the cannula after the newly created tracheostoma was already dilated.The patient was adequately preoxygenated and there was no significant drop in peripheral oxygen saturation.The physician involved in the case noted that an alternative suitable sized cannula could have been used or the patient could have continued to be ventilated via the endotracheal tube.The physician reported that there was no immediate risk.
Additional Manufacturer Narrative
A3 - date of event: date of event unknown, as the hospital is unable to provide information on incident dates d4 - lot: lot number unknown.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.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
It was clarified on 13jan2021 that a competitor's tracheostomy tube, which is pre-loaded over their guiding catheter, was used with and advanced directly over a cook guide wire from the blue rhino set.The loading dilator and guiding catheter provided in the cook blue rhino set were not used.The report of a cook guide wire not being compatible with a competitor's product has been reassessed and this event has been deemed not reportable as there is no precedence of the malfunction leading to an ae.

• 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: 11157892
• Report Number: 1820334-2021-00075
• Device Sequence Number: 631011
• Product Code: JOH
• UDI-Device Identifier: 00827002556249
• UDI-Public: (01)00827002556249(17)230801(10)13513644
• Combination Product (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 01/22/2021

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: 08/01/2023
• Device Model Number: N/A
• Device Catalogue Number: C-PTIS-350-HC-G
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 01/13/2021; 01/13/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 01/19/2021; 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRACOE VARIO XL TRACHEAL CANNULA