T-9 SCOOP PROCEDURE TRAY *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-12-14 for T-9 SCOOP PROCEDURE TRAY * manufactured by Transtracheal Systems.

Event Text Entries

[15576559] The scoop transtracheal was implanted pursuant to mfr's recommendation on (b)(6) 2011. On evening of (b)(6) 2011 the pt complained of some tightness and swelling in his face and neck, which he felt was caused by the chain collar. The chain collar could not be expanded and was replaced by a nurse with a soft commercial holder. On the morning of (b)(6) the pt sat up and began to rapidly desaturate, arrested and died. No autopsy was performed but the physicians believe the catheter had migrated to the soft tissue planes resulting in pneumomediastinum and generalized tissue emphysema.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5023491
• MDR Report Key: 2382536
• Date Received: 2011-12-14
• Date of Report: 2011-12-14
• Date of Event: 2011-11-18
• Date Added to Maude: 2011-12-21
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: T-9 SCOOP PROCEDURE TRAY
• Generic Name: T-9 PROCEDURE TRAY
• Product Code: BTO
• Date Received: 2011-12-14
• Model Number: T-9
• Catalog Number: *
• Lot Number: 0601
• ID Number: *
• Device Expiration Date: 2013-01-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TRANSTRACHEAL SYSTEMS
• Manufacturer Address: 14 INVERNESS DR E STE H-100 ENGLEWOOD CO 80112 US 80112

Device Sequence Number: 2

• Brand Name: C-9-2 SCOOP 9 CM ADULT
• Generic Name: C-9-2 CATHETER
• Product Code: KCG
• Date Received: 2011-12-14
• Model Number: C-9-2
• Lot Number: 2071
• Device Expiration Date: 2016-07-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: TRANSTRACHEAL SYSTEMS
• Manufacturer Address: 14 INVERNESS DR E STE H-100 ENGLEWOOD CO 80112 US 80112

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2011-12-14