GHIATAS

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, PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. 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

ON (B)(6) 2025, A PATIENT UNDERWENT A BREAST LOCALIZATION WIRE PLACEMENT USING GHIATAS LOCALIZATION WIRE. DURING THE PROCEDURE, THE OUTER SHEATH WAS BENT HALFWAY THROUGH AND DIFFICULT TO REMOVE IT FROM THE PATIENT WHILE ENSURING THE HOOKWIRE STAYED IN PLACE WITHIN THE BREAST TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

H11: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED, AND THIS LOT MET ALL RELEASE CRITERIA. INVESTIGATION SUMMARY: ONE ELECTRONIC PHOTO WAS PROVIDED AND REVIEWED. THE PHOTO SHOWS ONE GHIATAS LOCALIZATION CANNULA. A SEVERE BENT WAS NOTED ON THE CANNULA. NO OTHER VISUAL ANOMALIES WERE NOTED. BASED ON THE PHOTO REVIEW THE REPORTED BENT CAN BE CONFIRMED. ONE GHIATAS BEADED BREAST LOCALIZATION CANNULA WAS RECEIVED FOR EVALUATION. UPON VISUAL EVALUATION, THE CANNULA APPEARED TO BE CLEAN. MULTIPLE BENDS WERE NOTED TO THE CANNULA WHEN PLACED AGAINST A STRAIGHT EDGE RULER. DUE TO THE BENT CANNULA, NO FUNCTIONAL TESTING WAS PERFORMED. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED BENT AS A BENT WAS NOTED ON THE CANNULA HUB. HOWEVER, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED DIFFICULT TO REMOVE AND DIFFICULT TO ADVANCE AS THE CONDITION OF USE CANNOT BE REPLICATED IN THE LABORATORY. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED MATERIAL TWISTED/BENT, DIFFICULT TO ADVANCE AND DIFFICULT TO REMOVE ISSUE 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. D4 (UNIQUE IDENTIFIER (UDI) #), G3, H4, H6 (DEVICE, 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 LOCALIZATION WIRE PLACEMENT USING GHIATAS LOCALIZATION WIRE. DURING THE PROCEDURE, THE OUTER SHEATH WAS BENT HALFWAY THROUGH AND DIFFICULT TO REMOVE IT FROM THE PATIENT WHILE ENSURING THE HOOKWIRE STAYED IN PLACE WITHIN THE BREAST TISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.