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

Model Number	N/A
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient age at time of event is currently unknown as information was not provided.Patient sex at time of event is currently unknown as information was not provided.(b)(4).The event is currently under investigation.
Event or Problem Description
During a percutaneous tracheostomy procedure, there was a kink in the wire.The user did not notice this until dilator was over the wire.The part of the wire that was kinked got caught in the patient's stoma causing some laceration and extra bleeding.The user finished the procedure successfully with this device by repositioning the wire.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects other than minor bleeding due to this occurrence.
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
There was a kink in the wire.They did not notice this until dilator was over the wire.The part of the wire that was kinked got caught in the patient's stoma causing some laceration and extra bleeding.They finished procedure successfully with this device by repositioning the wire.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation.A review of complaint history, instructions for use (ifu), manufacturing instructions, specifications, trends and quality control was conducted during the investigation.The device is shipped with an ifu that describes the intended use, specific items are addressed such as: "exercise care to ensure that the components used in each step are properly positioned within the trachea.Improper placement of the components may lead to potentially life-threatening injury.It also states "bronchosopic 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." "introduce the j-tipped wire guide several centimeters into the trachea.Note: the wire should advance freely, without resistance.If resistance is encountered, do not force wire guide.Confirm correct fep sheath or introducer needle placement via bronchoscopy, then advance wire guide into the trachea until the distal mark on the wire guide reaches skin level".Since this device is inspected 100% for bends, kinks, adequate joint strength, correct outside dimension and other surface imperfections prior to transport, it is plausible to suggest that the wire guide met with resistance beyond its intended design during a procedurally related event.There is no evidence to suggest the product was not manufactured to current specifications.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints and have notified the appropriate internal personnel of this event.
Event or Problem Description
During a percutaneous tracheostomy procedure, there was a kink in the wire.The user did not notice this until dilator was over the wire.The part of the wire that was kinked got caught in the patient's stoma causing some laceration and extra bleeding.The user finished the procedure successfully with this device by repositioning the wire.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not require any additional procedures nor experience any adverse effects other than minor bleeding due to this occurrence.

• Brand Name: CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER TRAY
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5488798
• Report Number: 1820334-2016-00118
• Device Sequence Number: 498848
• Product Code: JOH
• UDI-Device Identifier: 00827002125131
• UDI-Public: (01)00827002125131(17)170301(10)6174750
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2016

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-PTISY-100-HC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/09/2016
• Device Age: 5 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/11/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/09/2016
• Supplement Report FDA Received Date: 03/11/2016; 06/13/2016
• 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