BREAST LOCALIZATION NEEDLE
Received Apr 20, 2012 · Event occurred Mar 18, 2010
Report 1036710-2012-00005 · MDR key 2546696
Device
Product problems
- Difficult to Remove
- Improper or Incorrect Procedure or Method
- Device Or Device Fragments Location Unknown
Patient
Not reported
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
THE REPORT RECEIVED IS BASED OFF INFO SUPPLIED BY THE PT. ALLEGEDLY AN ANGIOTECH MEDICAL DEVICE TECHNOLOGIES BREAST LOCALIZATION NEEDLE WAS USED. THE PART AND LOT NUMBER INFO IS UNK. THE WIRE USED WENT THROUGH THE CHEST WALL AND INTO THE LUNG. DUE TO UNK INFO WE ARE UNABLE TO CONFIRM. WE WILL CONTINUE TO MONITOR AND TREND.
Description of Event or Problem
DURING THE NEEDLE LOCALIZATION PROCESS, THE WIRE WAS INADVERTENTLY INSERTED THROUGH THE CHEST WALL AND INTO THE LUNG. THE PT WAS TAKEN TO THE OPERATING ROOM FOR EXCISION OF BREAST TISSUE AND THE WIRE COULD NOT BE LOCATED AND REMOVED DUE TO THE MISPLACEMENT OF THE WIRE. THE PT REQUIRED AN ADDITIONAL SURGICAL PROCEDURE TO LOCATE AND REMOVE THE WIRE.