MAUDE Adverse Event Report: COOK INC DOLPHIN BT; JOH TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Device name: dolphin bt ciaglia balloon-assisted percutaneous tracheostomy introducer set with shiley.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 balloon of a dolphin bt ciaglia balloon-assisted percutaneous tracheostomy introducer set with shiley ruptured during use for a percutaneous tracheostomy procedure.The balloon was being used to form the tracheal stoma when it ruptured in the patient's airway during inflation.The physician was unable to remove the device from the stoma, so another physician was called to assist.The device was then cut externally and removed retrograde under direct vision.No other adverse effects to the patient have been reported.Additional information regarding the event and device has been requested but is currently unavailable.
Event or Problem Description
Additional information regarding the device and event was received on 03mar2020.It was reported that though the balloon popped, it did not separate.Therefore, no foreign bodies had to be removed from the patient.It was also reported that the stoma was created by the balloon before it popped, so the procedure was still able to be completed.
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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation.(b)(6) hospital informed cook on 21feb2020 of an incident involving a dolphin bt ciaglia balloon-assisted percutaneous tracheostomy introducer set with shiley (rpn: c-ptbs-2800-perc8) from lot # 8371706.The balloon ruptured in the airway during inflation.Further communication with the user facility clarified that the balloon did not separate from the catheter; the device had to be cut externally and removed retrograde from the trachea under direct vision, and the procedure was still able to be completed.No additional adverse effects to the patient were reported.A review of the complaint history, device history record (dhr), drawing, instructions for use (ifu), and quality control, as well as a visual inspection of the returned device was conducted during the investigation.One ptbs set was returned to cook for investigation.A visual inspection of the device showed the balloon catheter inserted in the dilator and cut into three sections.The balloon appeared to have ruptured circumferentially.No other damage, besides biomatter, was noted.Due to the damaged condition the balloon was in, no further dimensional analysis was able to be completed.At this time, cook could not conclude that the device was manufactured out of specification.Additionally, a document-based investigation evaluation was conducted.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the design history file found that the affected device is both safe and effective for its intended use.A review of the dhrs for the reported device lot (8371706) and the related set/sub-assembly lots revealed no recorded non-conformances.A database search found no additional events associated with the reported device lot.At this time, there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.Cook also reviewed product labeling.The product ifu, ¿dolphin bt ciaglia balloon-assisted tracheostomy introducer set/tray,¿ provides the following information to the user related to the reported failure mode: warnings: ¿ do not exceed 11 atm.Over-inflation may cause rupture of the balloon, with resultant damage to the tracheal wall.Use of a pressure gauge is required to monitor inflation pressures.¿ precautions: ¿the balloon is constructed of a heat-sensitive material.Do not heat or attempt to shape the catheter tip.Use only the recommended balloon inflation medium.Never use air or any gaseous medium to inflate the balloon.Do not pre-inflate the balloon to check for air leaks.This may potentially cause inadequate inflation during the procedure¿ instructions for use: ¿21.While maintaining the visual reference points and positioning relationships of the wire guide and balloon catheter assembly, inflate the balloon.Note: digital stabilization of the balloon catheter should be maintained during initial inflation of the balloon.Slide the lock lever on the cook inflation device to the left (disengage) to allow free movement of the plunger.Inflate the balloon firmly and then slide the lock lever back to the right (engage).This will maintain the pressure and allow higher inflation pressures to be reached.Using the palm grip, rotate clockwise until the desired pressure is reached.Note: to avoid balloon rupture, do not exceed 11 atm.¿ based on the information provided, inspection of the returned product, and the results of the investigation, a definitive root cause was traced to component failure without a manufacturing or design deficiency.It is possible that the balloon was over-inflated above 11 atm, but this was not confirmed.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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: DOLPHIN BT
• Common Device Name: JOH TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9764616
• Report Number: 1820334-2020-00484
• Device Sequence Number: 687996
• Product Code: JOH
• UDI-Device Identifier: 00827002361171
• UDI-Public: (01)00827002361171(17)200915(10)8371706
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K093469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/15/2020
• Device Model Number: N/A
• Device Catalogue Number: C-PTBS-2800-PERC8
• Device Lot Number: 8371706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 03/03/2020; 04/02/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 03/12/2020; 04/08/2020
• 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: Required Intervention