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

Model Number	G53172
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
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.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 reported that the wire guide from a ciaglia blue rhino percutaneous tracheostomy introducer set elongated and unraveled during tracheostomy tube placement.After placing the dilator, the guiding catheter and wire guide were difficult to remove as they were "stuck." the doctor "pulled hard" and was able to remove them.After removal it was noted that the wire was "deformed." a provided photo shows the wire guide had elongated and unraveled.It was noted that there was no difficulty advancing the wire guide, and the wire guide was not manipulated or withdrawn through the needle.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation it was reported that the wire guide from a ciaglia blue rhino percutaneous tracheostomy introducer set elongated and unraveled during tracheostomy tube placement.After placing the dilator, the guiding catheter and wire guide were difficult to remove as they were "stuck".The doctor "pulled hard" and was able removed them.After removal it was noted that the wire was "deformed".A provided photo shows the wire guide had elongated and unraveled.It was noted that there was no difficulty advancing the wire guide, and the wire guide was not manipulated or withdrawn through the needle.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the documentation, including the complaint history, device history record, quality control procedures, manufacturing instructions (mi) and instructions for use (ifu) for the device, as well as visual inspection and dimensional verification of the returned product, were conducted during the investigation.Cook received one used wire guide from the customer.A visual examination of the wire guide found the wire had elongated and unraveled; the weld balls were intact.Dimensional analysis confirmed that the device and components were manufactured to the correct specifications and tolerances.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) for the device found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that there were no other complaints associated with the final product lot number.Cook also reviewed product labeling: the product ifu, [c_t_ptisg_rev4] ¿ciaglia blue rhino g2 advanced percutaneous tracheostomy introducer,¿ 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 trachea.¿ instructions for use ¿9.Introduce the j-tipped wire guide several cm into the trachea.Note: the wire should advance freely, without resistance.If resistance is encountered, do not force wire guide.¿ evidence gathered upon review of dmr, product labeling, dhr and device failure analysis, does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, examination of the returned product, and the results of our investigation, it was concluded that a component failure unrelated to design or manufacturing deficiencies contributed to the reported event.It¿s possible that the wire guide became damaged while inside the patient, however cook cannot confirm this.Per the risk assessment no further action is required.The appropriate personnel have been notified.Cook 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 20091268
• Report Number: 1820334-2024-01134
• Device Sequence Number: 7810480
• Product Code: JOH
• UDI-Device Identifier: 00827002531727
• UDI-Public: (01)00827002531727(17)261213(10)15804311
• Combination Product (Y/N): N
• PMA/510(K) Number: K133597
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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 Model Number: G53172
• Device Catalogue Number: C-PTIS-100-FLEX-HC-G
• Device Lot Number: 15804311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 65 KG