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Adverse Event Report

COOK CRITICAL CARE A DIVISION OF COOK, INC. COOK CRITICAL CARE PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET   back to search results
Catalog Number C-PTS-100
Device Problem Insertion difficulties
Event Date 12/09/1998
Patient Outcome  Death;
Event Description

Percutaneous tracheostomy was attempted, following prolonged endotracheal intubation, it was planned and performed at the bedside in the critical care unit. The procedure was difficult, and unsuccessful attempts were made for emergency tracheostomy and et tube placement as well. During the procedure, she experienced subcutaneous emphysema and arrested. An et tube was eventually placed, however, resuscitation was not successful.

 
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Brand NameCOOK CRITICAL CARE
Type of DevicePERCUTANEOUS TRACHEOSTOMY INTRODUCER SET
Baseline Brand NameCIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER
Baseline Generic NameNA
Baseline Catalogue NumberC-PTS-100
Baseline Device FamilySPECIAL SETS
Baseline Device 510(K) Number
Baseline Device PMA Number
Baseline Shelf Life Information Yes
Baseline Preamendment? Yes
Transitional? No
510(K) Exempt? No
Shelf Life(Months)36
Manufacturer (Section D)
COOK CRITICAL CARE A DIVISION OF COOK, INC.
po box 489
bloomington IN 47402
Device Event Key202137
MDR Report Key208256
Event Key195482
Report Number208256
Device Sequence Number1
Product CodeBTO
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/29/1998,12/10/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/02/1999
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberC-PTS-100
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/29/1998
Distributor Facility Aware Date12/10/1998
Event Location Hospital
Date Report TO Manufacturer12/29/1998
Is the Device an Implant? Yes
Is this an Explanted Device? No Answer Provided

Database last updated on February 28, 2009

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