DUALOK LOCALIZATION WIRE

Additional Manufacturer Narrative

H11: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUIRED AS THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS PRODUCT AND LOT. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. ONE RADIOGRAPHS IMAGE WAS PROVIDED AND REVIEWED. PHOTOGRAPHS OF CC AND ML RIGHT BREAST MAMMOGRAPHS PERFORMED FOLLOWING WIRE LOCALIZATION. THE SUBMITTED IMAGES SHOW A FRACTURED DUALOK WIRE. THE DISTAL PORTION OF THE WIRE IS WITHIN THE LOWER RIGHT BREAST ENTIRELY WITHIN THE BREAST. THE MACROCALCIFICATIONS THAT WERE TARGETED ARE NOT VISIBLE ON THIS PHOTOGRAPH WHICH WAS TAKEN SOME DISTANCE FROM THE MONITOR. IT IS UNCLEAR HOW THE LOCATION OF THE WIRE TIP RELATED TO THE CALCIFICATIONS. THE PROXIMAL PORTION OF THE WIRE IS INTACT. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED BREAK AS THE WIRE WAS NOTED TO BE BROKEN. A DEFINITIVE ROOT CAUSE FOR THE BREAK COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: AS THE REPORTED EVENT DID NOT ALLEGE A LABELING OR USE RELATED ISSUE, A LABELING REVIEW IS NOT REQUIRED. B5, G3, H6 (DEVICE, METHOD, RESULT, CONCLUSION). SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.

Description of Event or Problem

ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST LOCALIZATION WIRE PROCEDURE USING THE DUALOK WIRE. DURING THE PROCEDURE, IT WAS REPORTED THAT END OF THE DEVICE WIRE WAS BROKEN. IT WAS FURTHER REPORTED THAT THE BROKEN WIRE WAS STILL INSIDE PATIENT BREAST. THERE WAS REPORTED PATIENT INJURY. THE CURRENT STATUS OF THE PATIENT IS GOOD.

Additional Manufacturer Narrative

H11: AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, IMAGES WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. SECTION A THROUGH F: THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.

Description of Event or Problem

ON (B)(6) 2026, A PATIENT UNDERWENT A BREAST LOCALIZATION WIRE PROCEDURE USING THE DUALOK WIRE. DURING THE PROCEDURE, THE DEVICE WIRE WAS BROKEN AND DIFFICULT TO REMOVE THE WIRE FROM THE PATIENT. THERE WAS REPORTED PATIENT INJURY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.