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

Catalog Number C-VTIC-8

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medwatch report number (b)(4) received on (b)(6) 2018 stated a versatube¿ tracheostomy tube inner cannula had broken.The device was removed during a trach exchange and replaced with a like device.The patient experienced bleeding at the site and hemoptysis which required fio2 to increase from 28% to 40%.Additional information provided stated the flange on the tracheostomy tube broke which caused irritation due to the loose fitting.Of note, the facility speculates the irritation could have been caused by pulmonary edema as well.As reported, the trach exchange "definitely" caused the patient to bleed.This result has been reported on mdr 1820334-2018-03410.

Event Description

Additional information was provided by the customer on (b)(6) 2018.The patient was admitted into the hospital (b)(6) 2018 after having been found unresponsive with emesis and incontinence of urine.Blood was noted in left nostril.The patient was diagnosed with large right basal ganglia intracerebral hemorrhage with some intraventricular extension and midline shift.The patient was positive for methamphetamines and diagnosed with malignant hypertension.The patient had a prior pontine stroke due to methamphetamine use resulting in residual right side weakness.The patient¿s sputum was determined to be positive for beta (¿)-haemolytic streptococci.On (b)(6) 2018 the patient continued to have cerebral edema with transfalcine herniation that required a right craniotomy for evacuation of the intracranial hemorrhage (ich).The patient was placed on a ventilator.On (b)(6) 2018, the patient had a percutaneous tracheostomy placed bedside with bronchoscopy.On (b)(6) 2018, the patient was placed on a t-piece with ventilation standby.The patient was continually attached to the ballard t-piece suction due to increased thick secretions.The tracheostomy sutures were removed (b)(6)2018.On (b)(6) 2018, the patient was placed in the step down unit.On (b)(6) 2018, the patient experienced decreased mental status throughout the shift, as well as decreased blood pressure, increased temperature and increased trach secretions.The sputum culture revealed gram negative rods and the patient was started on metaneb.On 29sep2018, staff noted pink, frothy secretions that continued through 01oct2018.On (b)(6) 2018 the tracheal flange was noted to be broken and a new shiley #8 was placed.As reported, trach care was done twice daily and prn.See manufacturer report #1820334-2018-03410 for further details of the trach replacement procedure involving a cook airway exchange catheter.

Manufacturer Narrative

Blank fields on this form indicate the information has previously been reported, is unknown or is unavailable.Additional information 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.

Manufacturer Narrative

Device evaluation: the complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.Investigation: a document-based investigation reviewed the following: documentation, instructions for use, quality control specifications, and specifications.The manufacturer has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The lot number of the device is not known; accordingly, a review of the device history record and complaint lot search could not be conducted.Clinical assessment: there is no evidence to suggest a causal relationship between the broken tracheostomy flange and the hemoptysis.Based on current information, the most probable causes of this event are infection, suctioning and/or airway exchange catheter related.Per the ifu: ¿warnings: do not use and inner cannula when using a tracheostomy tube in conjunction with a right-angled connector that incorporates a coaxial fresh gas tube which protrudes into the connector lumen (e.G., norman elbow).The protruding fresh gas tube could occlude the inner cannula, restricting expiratory flow of gas and resulting in barotrauma/hypoxia.During and after attachment of the breathing system to the tracheostomy tube connector, avoid excessive rotational or linear forces on the tube; application of such forces may result in tube kinking, disconnection, or occlusion.Instructions for use: caution: this product is composed of soft materials to conform to tracheal tissue for performance and patient comfort.Simple precautions in handling of this tube during insertion and while in place will facilitate proper function and minimize tears and breaks in the inflation system.Avoid pulling or manipulation of the inflation line, as it is designed to conduct and hold air as part of the cuff inflation system.It is recommended that the inflation line be maintained in a position allowing for patient mobility without placing tension on the line-to-cannula junction.How supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ conclusion: based on the information provided, no product returned, and the results of our investigation, a definitive root cause could not be determined.Per the [quality engineering] risk assessment, no further action is required.The appropriate personnel will be notified and we will continue to monitor for similar complaints.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 Description

No new event description information to report at this time.

• Brand Name: VERSATUBE¿ TRACHEOSTOMY TUBE INNER CANNULA
• Type of Device: BTO TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8053897
• MDR Text Key: 126642222
• Report Number: 1820334-2018-03193
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: C-VTIC-8
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/15/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 10/29/2018; 02/04/2019
• Supplement Dates FDA Received: 11/28/2018; 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK AIRWAY EXCHANGE CATHETER
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 52 YR