MAUDE Adverse Event Report: COVIDIEN SHIL, TRACHEOSTOMY

Catalog Number TRACH

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Death (1802)

Event Date 04/21/2012

Event Type  Death  

Event Description

Covidien received a litigation complaint and related document on (b)(6) 2014.Covidien clinical team has reviewed the documents and summarized the reported circumstances of this event as follows: "on (b)(6) 2012, a patient underwent a surgical procedure for tracheal stenosis where the physician was unsuccessful at passing their smallest bronchoscopy tube.A tracheostomy tube was then placed.The patient tolerated the procedure well and recovered in the intensive care unit (icu).On (b)(6) 2012, the patient was transferred to the floor and continued to recover.On (b)(6) 2012, the patient had a respiratory arrest and expired.The physician who examined the patient believed the tracheostomy tube to be in the appropriate position as it was secured with four separate sutures.By the time of the autopsy, the tracheostomy tube had become dislodged from the trachea.It was also noted on autopsy that the tracheostomy tube was sufficiently sutured onto the skin surface overlying the trachea.".

Manufacturer Narrative

(b)(4).No additional information available.

• Brand Name: SHIL, TRACHEOSTOMY
• Type of Device: UNK
• Manufacturer (Section D): COVIDIEN; avenida henequen; cd. juarez, chilhuahua ; MX
• Manufacturer (Section G): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez, chilhuahua ; MX
• Manufacturer Contact: denise braxton ; 6135 gunbarrel ave.; boulder, CO 80301 ; 3038768909
• MDR Report Key: 3850987
• MDR Text Key: 15177365
• Report Number: 2936999-2014-00393
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/25/2014

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
• Device Operator: Other
• Device Catalogue Number: TRACH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2014
• Initial Date FDA Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 29 YR