DUALOK LOCALIZATION WIRE

Additional Manufacturer Narrative

H10: 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. H10: D4 (EXPIRY DATE: 12/2026) H11: SECTION A THROUGH F: THE INFORMATION PROVIDE 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

IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED LOCALIZATION WIRE PLACEMENT PROCEDURE, THE WIRE HAD TO BE REPOSITIONED AND RE-SHEATHED. IT WAS FURTHER REPORTED THAT AT THE TIME OF PERFORMING MAMMOGRAPHY FOR ITS VERIFICATION, ONE OF ITS HOOKS WAS ALLEGEDLY BROKEN, MOVING AND NOT BEING ABLE TO STAY SECURELY IN THE BREAST. FURTHERMORE, AS IT WAS ALREADY IN POSITION IN THE BREAST, THE PHYSICIAN DECIDED TO LEAVE IT IN POSITION FIXED ON THE OUTSIDE WITH MESH AND PATCHES. REPORTEDLY, SURGICAL INTERVENTION WAS PERFORMED TO REMOVE THE BROKEN FRAGMENTS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED LOCALIZATION WIRE PLACEMENT PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE WIRE HAD TO BE REPOSITIONED AND RE-SHEATHED. IT WAS FURTHER REPORTED THAT AT THE TIME OF PERFORMING MAMMOGRAPHY FOR ITS VERIFICATION, ONE OF ITS HOOKS WAS ALLEGEDLY BROKEN, MOVING AND NOT BEING ABLE TO STAY SECURELY IN THE BREAST. FURTHERMORE, AS IT WAS ALREADY IN POSITION IN THE BREAST, THE PHYSICIAN DECIDED TO LEAVE IT IN POSITION FIXED ON THE OUTSIDE WITH MESH AND PATCHES. REPORTEDLY, SURGICAL INTERVENTION WAS PERFORMED TO REMOVE THE BROKEN FRAGMENTS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

Additional Manufacturer Narrative

H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. ONE RADIOGRAPH IMAGE WAS PROVIDED AND REVIEWED. RIGHT BREAST CC AND LM MAMMOGRAMS PERFORMED FOLLOWING WIRE LOCALIZATION. ADDITIONALLY, THERE ARE SPECIMEN RADIOGRAPHS (FOLLOWING SURGERY). THE SUBMITTED IMAGES SHOW 1 WIRE WITHIN THE RIGHT BREAST, WHICH IS ADJACENT TO A BREAST TISSUE MARKER (PRESUMABLY THE TARGET FOR LOCALIZATION). DUALOK WIRES HAVE 2 HOOKS AT THE TIP WHICH HOLD THE WIRE IN PLACE. THIS WIRE ONLY HAS 1 HOOK ATTACHED, AND THERE IS AN ADJACENT HOOKED PIECE OF METAL WHICH IS PRESUMABLY THE OTHER HOOK THAT HAS BROKEN OFF. THE SPECIMEN RADIOGRAPH SHOWS THE TISSUE MARKER, MULTIPLE SURGICAL CLIPS, AND THE SMALL HOOKED PIECE OF METAL WHICH IS ALLEGEDLY THE BROKEN PART OF THE PREVIOUSLY DESCRIBED WIRE. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED BREAK AS ONE HOOK OF THE WIRE WAS NOTED BE BROKEN. A DEFINITIVE ROOT CAUSE FOR THE REPORTED 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. H11: 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.