inforMED
OtherGBW

COOK

Received Sep 23, 2008 · Event occurred Aug 5, 2008

Report 1179624 · MDR key 1179624

Device

Generic name

Guidewire

Manufacturer

Cook Medical

Model number

UNK

Catalog number

UNK

Lot number

UNK

Product problems

  • Malfunction

Patient

2 *

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

USING STERILE SELDINGER TECHNIQUE, A 16 FR CHEST TUBE WAS BEING INSERTED INTO THE LEFT CHEST OF THE PT. AS THE DILATORS WERE BEING USED TO ENLARGE THE ENTRY SITE OVER THE WIRE, THE WIRE WAS NOTED TO BE FRAYED AND UNWINDING. THE WIRE WAS REMOVED FROM THE PT, IN TOTAL, AND A NEW KIT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ADVERSE OUTCOME WAS NOTED FOR THE PT.