MAUDE Adverse Event Report: COOK INC VERSATUBE¿ TAPERED TRACHEOSTOMY TUBE; BTO TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number C-VT-9

Device Problem Inflation Problem (1310)

Patient Problems Airway Obstruction (1699); No Code Available (3191)

Event Date 02/06/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: unknown.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported the versatube¿ tapered tracheostomy tube repeatedly deflated in an icu patient.Initial inflation of the cuff demonstrated no obvious tears or leaks, however, the cuff developed leaks 1-2 weeks post insertion each time.The patient was treated with either a tracheostomy tube change or a cap attached to the pilot tube which resolved the cuff leak.The patient required 4 reinsertions of a new size 9 versa tube during icu admission.As reported, the patient was ventilated during the night and on a tracheostomy hood during the day.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.This report references the fourth versa tube deflation event.Three previous occurrences of tube deflation can be referenced in mfr.Report # 1820334-2019-00498, mfr.Report # 1820334-2019-00499 and mfr.Report # 1820334-2019-00500.Additional information regarding event details and patient outcome has been requested, but is not available at this time.The third tracheostomy inserted was kept and is being sent in for evaluation.

Manufacturer Narrative

Investigation: evaluation: a review of the drawing, instructions for use, quality control, as well as a functional test and visual inspection of the returned device was conducted during the investigation.One device was returned for evaluation.A visual examination notes that the balloon can inflate and deflate without issue.No leaks are noted in the device.The customer¿s difficulty could not be recreated during the investigation.Additionally, a document-based investigation evaluation was performed.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The risk specification for this product includes the loss of use failure mode and identifies the controls that are in place to mitigate the risk of this type of failure.A review of the device history record could not be completed, as the lot information is unknown.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings: cuff pressure should be monitored and adjusted routinely and should never exceed 25mm hg.Over-inflation of the cuff may inhibit ventilation and may also result in permanent damage to the trachea.Under inflation of the cuff may result in aspiration of subglottic secretions leading to lung infections.Prior to removal of cuffed tracheostomy tubes, ensure that all air is completely removed from the cuff; failing to do so may result in pain to the patient and damage to the trachea and/or stoma.Precautions: for ventilator dependent patients, a replacement tracheostomy tube should be kept at bedside and cuff inflation should be monitored regularly.Instructions for use: tube preparation 2.Test the cuff and inflation system for leakage.3.With the cuff deflated, taper the cuff back by gently moving away from the distal tip of the outer cannula toward the swivel neck plate as the residual air is removed by deflation.This will ease insertion and guard against cuff perforation by sharp instruments such as forceps or hemostats to taper the cuff; doing so may result in cuff damage.Insertion - 9.Inflate the low-pressure cuff by injecting air into the luer valve of the inflation line using a syringe.Selection of a cuff inflation and deflation method is at the discretion of the physician/hospital.Based on the information provided, examination of the returned product and the results of our investigation, no problem with the device could be detected.A quality engineer risk assessment was conducted to assess the risk of this failure mode and concluded no risk reduction activities are required at this time.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 Description

It was originally reported that the device from the third event (mfr.Report#: 1820334-2019-00498) would be returned for evaluation.The device was returned to the manufacturer for evaluation and the investigation is linked to this event.

• Brand Name: VERSATUBE¿ TAPERED TRACHEOSTOMY TUBE
• Type of Device: BTO TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8358573
• MDR Text Key: 136782563
• Report Number: 1820334-2019-00497
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• PMA/PMN Number: K100283
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-VT-9
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR