GHIATAS LOCALIZATION WIRE

Additional Manufacturer Narrative

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, AN IMAGE WAS PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 04/2023).

Description of Event or Problem

IT WAS REPORTED THAT POST PLACEMENT OF A BREAST LOCALIZATION WIRE, AN ARTIFACT WAS ALLEGEDLY FOUND ON MRI IMAGES. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

H10: 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 MEDICAL IMAGE (MRI) WAS PROVIDED AND REVIEWED. THE PROVIDED IMAGE IS A SAGITTAL MR IMAGE WITH GRADIENT ARTIFACT THAT IS MORE THAN EXPECTED AROUND THE LOCALIZATION WIRE. THE ARTIFACT IS MORE THAN EXPECTED. BASED ON THE IMAGE REVIEW, THE REPORTED FAILURE IS CONFIRMED AS THE IMAGE REVIEW DEMONSTRATED AN ARTIFACT. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED ARTIFACT COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: THE REVIEW OF THE INSTRUCTIONS FOR USE, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, AND CONTRAINDICATIONS SHOWED THAT THE PRODUCT LABELING IS ADEQUATE. H10: D4 (EXPIRY DATE: 04/2023). H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

Description of Event or Problem

IT WAS REPORTED THAT POST PLACEMENT OF A BREAST LOCALIZATION WIRE, AN ARTIFACT WAS ALLEGEDLY FOUND ON MRI IMAGES. THERE WAS NO REPORTED PATIENT INJURY.