GHIATAS LOCALIZATION WIRE

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. ADDITIONALLY, IT WAS DETERMINED THAT NO ACTION IS REQUIRED BASED ON THE NUMBER OF EVENTS ASSOCIATED WITH THIS LOT NUMBER. INVESTIGATION SUMMARY: ONE GHIATAS LOCALIZATION WIRE WAS RETURNED FOR EVALUATION AND TWO MR IMAGES WERE PROVIDED FOR REVIEW. THE RETURNED SAMPLE COULD NOT BE FUNCTIONALLY EVALUATED AS THE CONDITIONS OF USE COULD NOT BE REPLICATED (I.E. MR IMAGING WITH PARAMETERS USED DURING PROCEDURE). PER THE IMAGE REVIEW PERFORMED, AN ARTIFACT WAS IDENTIFIED IN THE FIRST MR IMAGE PROVIDED WITH MINIMAL ARTIFACT IDENTIFIED IN THE SECOND IMAGE PROVIDED. AS SUCH, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED ARTIFACT. PER THE GHIATAS INSTRUCTIONS FOR USE, "NON-CLINICAL TESTING HAS DEMONSTRATED THAT THE MR GHIATAS® LOCALIZATION WIRE IS MR CONDITIONAL. IT CAN BE SCANNED SAFELY UNDER THE FOLLOWING CONDITIONS: STATIC MAGNETIC FIELD OF 3-TESLA OR LESS SPATIAL GRADIENT FIELD OF 720-GAUSS/CM OR LESS IN NON-CLINICAL TESTING, THE MR GHIATAS® LOCALIZATION WIRE PRODUCT CODES PRODUCED A TEMPERATURE RISE OF LESS THAN +0.9°C AT A MAXIMUM MR SYSTEM REPORTED WHOLE BODY AVERAGED SPECIFIC BODY ABSORPTION RATE (SAR) OF 3-W/KG OF 15-MINUTES OF MR SCANNING IN A 3-TESLA, SIGNA MR SYSTEM (EXCITE PLATFORM; G3.0-052B SOFTWARE, GE HEALTHCARE, MILWAUKEE, WI). MR IMAGE QUALITY MAY BE COMPROMISED IF THE AREA OF INTEREST IS IN THE EXACT SAME AREA OR RELATIVELY CLOSE TO THE POSITION OF THE MR GHIATAS® LOCALIZATION WIRE. THEREFORE, IT MAY BE NECESSARY TO OPTIMIZE MR IMAGING PARAMETERS FOR THE PRESENCE OF THIS METALLIC IMPLANT." AS SUCH, IT IS POSSIBLE THAT IMAGING PARAMETERS CONTRIBUTED TO THE REPORTED ARTIFACT. HOWEVER, THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: THE REVIEW OF THE IFU (INSTRUCTIONS FOR USE), INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, AND CONTRAINDICATIONS SHOWED THAT THE PRODUCT LABELING IS ADEQUATE.

Description of Event or Problem

IT WAS REPORTED THAT POST PLACEMENT OF A LOCALIZATION WIRE, AN ARTIFACT ALLEGEDLY WAS FOUND ON MRI IMAGING. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE CURRENT PATIENT STATUS IS UNKNOWN.

Additional Manufacturer Narrative

THE LOT NUMBER OF THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE RETURN OF THE SAMPLE IS PENDING. THE PHOTO REVIEW IS CURRENTLY UNDERWAY REVIEW. THE INVESTIGATION IS CURRENTLY UNDERWAY. (EXPIRY DATE: 02/2022).

Description of Event or Problem

IT WAS REPORTED THAT POST PLACEMENT OF A LOCALIZATION WIRE, AN ARTIFACT ALLEGEDLY WAS FOUND ON MRI IMAGING. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.