GELMARK ULTRA BREAST TISSUE MARKER

Additional Manufacturer Narrative

H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED IS UNKNOWN. INVESTIGATION SUMMARY: ONE GELMARK ULTRA MARKER APPLICATOR WAS RECEIVED WITH THEIR TIP GUIDE. DURING VISUAL EVALUATION, THE DEVICE APPEARED TO HAVE RESIDUE THROUGHOUT. ALSO THE MARKER APPLICATOR WAS NOTED TO BE IN A PRE- DEPLOYED CONFIGURATION AND NO PADS WERE PRESENT. SLIGHT BEND NOTED TO THE PROXIMAL END OF THE PLUNGER, A CIRCUMFERENTIAL BREAK WAS NOTED TO THE DISTAL END OF THE MARKER APPLICATOR. UNDER X-RAY EXAMINATION, THE RETURNED DEVICE WAS NOTED TO HAVE A MARKER STUCK AT THE DISTAL END OF THE MARKER APPLICATOR. NO OTHER ANOMALIES WERE NOTED. DUE TO THE CONDITION OF THE RETURNED DEVICE, NO FUNCTIONAL TESTING PERFORMED. THEREFORE, THE INVESTIGATION IS CONFIRMED FOR THE REPORTED BENT AS RETURNED DEVICE WAS NOTED TO BE BENT AND THE INVESTIGATION IS INCONCLUSIVE FOR POSITIONING FAILURE DUE TO THE CONDITION OF THE RETURNED DEVICE (IDENTIFIED BREAK). THE INVESTIGATION IS UNCONFIRMED FOR POOR IMAGE QUALITY AS UNDER X-RAY EVALUATION, THE WIRE-FORM WAS NOTED TO BE STUCK AT THE DISTAL END OF THE MARKER APPLICATOR. THE INVESTIGATION IS CONFIRMED FOR THE IDENTIFIED BREAK ISSUE AS A CIRCUMFERENTIAL BREAK WAS NOTED TO THE DISTAL END OF THE MARKER APPLICATOR. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED FAILURE TO DEPLOY, POOR QUALITY IMAGE, BENT NEEDLE AND IDENTIFIED BREAK ISSUES 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 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 A BREAST TISSUE MARKER PLACEMENT PROCEDURE, THE MARKER WAS ALLEGEDLY NOT PLACED SMOOTHLY. IT WAS FURTHER REPORTED THAT THE INSERTED MARKER CLIP WAS NOT SEEN. FURTHERMORE, THE ENTIRE NEEDLE WAS ALLEGEDLY SKEWED WHEN IT WAS PULLED OUT. THERE WAS NO REPORTED PATIENT INJURY.