MAUDE Adverse Event Report: MEDTRONIC / COVIDIEN SHILEY FLEX / MEDTRONIC SHILEY FLEX TRACHEOSTOMY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problems Tidal Volume Fluctuations (1634); Positioning Problem (3009); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Cardiac Arrest (1762); Failure of Implant (1924)

Event Date 09/15/2021

Event Type  Death  

Event Description

Patient placed with a medtronic shiley flex 6.Significant cuff leak noted and inability to maintain tidal volumes.Trach was exchanged with 7 shiley xlt resulted in a right mainstem of the tracheostomy.New 6 shiley placed.New trach was not in trachea, patient unable to be ventilated.Et tube placed, patient coded and expired.Fda safety report id # (b)(4).

• Brand Name: SHILEY FLEX / MEDTRONIC SHILEY FLEX TRACHEOSTOMY
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): MEDTRONIC / COVIDIEN
• MDR Report Key: 12632465
• MDR Text Key: 276724722
• Report Number: MW5104577
• Device Sequence Number: 1
• Product Code: BTO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/08/2021
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Weight: 98