DUALOCK BREAST LOCALIZATION WIRE

Additional Manufacturer Narrative

AFTER FURTHER CLINICAL REVIEW, THIS EVENT WAS REASSESSED AND DETERMINED TO BE NOT MDR REPORTABLE. ALTHOUGH, THIS EVENT IS NOT MDR REPORTABLE, AN INITIAL MDR HAS ALREADY BEEN SUBMITTED; THEREFORE, THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO DOCUMENT THE CHANGE IN REPORTABILITY AND ADDITIONAL PRODUCT DETAILS.

Additional Manufacturer Narrative

NO HOSPITAL/MEDICAL RECORDS OR MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

Description of Event or Problem

IT WAS REPORTED THAT DURING A BREAST LOCALIZATION WIRE PROCEDURE, THE WIRE WAS DEPLOYED INTO THE BREAST BUT DID NOT EXPAND INTO ITS NORMAL CONFIGURATION. THE HCP DECIDED TO SEND THE PATIENT TO ANOTHER FACILITY TO PERFORM THE PROCEDURE AFTER THE WIRE FAILED TO EXPAND IN THE BREAST. THERE WAS NO REPORT OF PATIENT INJURY.