GHIATAS

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. SINGLE IMAGE WAS PROVIDED AND REVIEWED. THE SUBMITTED IMAGE SHOWS THE NEEDLE USED TO PLACE A LOCALIZATION WIRE. THE NEEDLE APPEARS TO BE VERY SLIGHTLY BENT AT THE TIP. THE TIP OF THE NEEDLE IS ADJACENT TO A RIBBON-SHAPED TISSUE MARKER, WHICH IS PRESUMABLY THE TARGET OF THE LOCALIZATION PROCEDURE. WIRE LOCALIZATION IS PERFORMED PRIOR TO SURGERY IN ORDER TO HELP THE SURGEON LOCATE THE AREA TO BE EXCISED IN THE OPERATING ROOM. THE WIRE IS PLACED BY THE RADIOLOGIST, WITH THE TIP OF THE WIRE AT THE SITE TO BE EXCISED AND THE PROXIMAL PORTION OF THE WIRE REMAINING OUTSIDE THE BREAST SO THAT THE SURGEON CAN FOLLOW THE WIRE FROM THE SKIN TO THE EXCISION LOCATION. INITIALLY, A BREAST LOCALIZATION NEEDLE IS PLACED INTO THE BREAST IN THE DESIRED LOCATION, AND THEN THE WIRE IS INSERTED INTO THE NEEDLE AND SUBSEQUENTLY DEPLOYED. IN THIS CASE, IT APPEARS THAT THE TIP OF THE NEEDLE WAS SOMEHOW VERY SLIGHTLY BENT. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED BENT AS THE NEEDLE APPEARS TO BE VERY SLIGHTLY BENT AT THE TIP AND THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED DIFFICULT TO REMOVE AND DIFFICULT TO INSERT AS NO OBJECTIVE EVIDENCE WAS PROVIDED FOR REVIEW. HOWEVER, DUE TO THE ABSENCE OF SUPPORTING EVIDENCE, THE REPORTED EVENT REMAINS INCONCLUSIVE FOR THE REMAINING THREE DEVICES. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED MATERIAL TWISTED/BENT, DIFFICULT TO REMOVE AND DIFFICULT TO INSERT 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. G3, H6 (DEVICE, COMPONENT, METHOD, RESULT, CONCLUSION). 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

ON (B)(6) 2025, A PATIENT UNDERWENT A BREAST MARKER PLACEMENT THROUGH THE GHIATAS LOCALIZATION WIRE. DURING THE PROCEDURE, THE NEEDLE WAS BENT AT THE TIP OF THE BEVEL. DUE TO THE BENT TIP, INSERTION INTO THE PATIENT'S SKIN WAS MORE DIFFICULT AND CAUSED THE SKIN TO TEAR WHEN IT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

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, PHOTOS 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) 2025, A PATIENT UNDERWENT A BREAST MARKER PLACEMENT THROUGH THE GHIATAS LOCALIZATION WIRE. DURING THE PROCEDURE, THE NEEDLE WAS BENT AT THE TIP OF THE BEVEL. DUE TO THE BENT TIP, INSERTION INTO THE PATIENT'S SKIN WAS MORE DIFFICULT AND CAUSED THE SKIN TO TEAR WHEN IT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.