MAUDE Adverse Event Report: COVIDIEN SHILEY; PERCUTANEOUS TRACHEOSTOMY TUBE

Catalog Number 8PERC

Device Problem Pressure Problem (3012)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888)

Event Date 01/01/2014

Event Type  Death  

Event Description

Customer reported that the pt was a cardiac intensive care unit (icu) pt.Rptr stated that following placement of the tube, the pt started experiencing cuff pressure issues and a decision was made to replace the 8perc with a xlt.It was reported that the pt experienced bleeding from the stoma site following replacement of the tube therefore; a decision was made to transfer the pt to the operating room (or) for a chest cavity procedure.Results of the procedure revealed the cuff was pressed against an artery.The customer stated that the pt had a poor heart condition and was not able to handle the trauma and resuscitation.The customer stated the heart condition was ultimately the cause of death but the recannulation created add'l trauma to the pt.(b)(4).2936999-2014-00133.

Manufacturer Narrative

(b)(4).Investigation efforts for the customer report are ongoing.A summary of the investigation results will be provided in a supplemental report.

• Brand Name: SHILEY
• Type of Device: PERCUTANEOUS TRACHEOSTOMY TUBE
• Manufacturer (Section D): COVIDIEN; avenida henequen; cd. juarez, chihuahua ; MX
• Manufacturer (Section G): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez ; MX
• Manufacturer Contact: denise braxton ; 6135 gunbarrel ave.; boulder, CO 80301 ; 3038768909
• MDR Report Key: 3669459
• MDR Text Key: 4347098
• Report Number: 2936999-2014-00136
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K884730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/13/2014

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8PERC
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/23/2014
• Initial Date Manufacturer Received: 01/13/2014
• Initial Date FDA Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention