GELMARK ULTRACOR MARKER

Additional Manufacturer Narrative

AFTER FURTHER REVIEW OF THE EVENT DETAILS, IT WAS DETERMINED THAT THE INABILITY TO SEE A TISSUE MARKER UNDER ULTRASOUND AND MAMMOGRAM (1408 - POOR QUALITY IMAGE) IS NOT AN ISSUE THAT IS LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS PATIENT INJURY. THERE WAS NO REPORTED PATIENT INJURY. THIS EVENT WAS REASSESSED AND DETERMINED TO BE NOT MDR REPORTABLE. HOWEVER, A SUPPLEMENTAL MDR HAS ALREADY BEEN SUBMITTED; THEREFORE, THE PURPOSE OF THIS SUPPLEMENTAL REPORT IS TO DOCUMENT THE CHANGE IN REPORTABILITY CLASSIFICATION. THE INFORMATION PROVIDED BY BARD 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 BARD.

Description of Event or Problem

IT WAS REPORTED THAT POST BREAST TISSUE MARKER PLACEMENT, THE MARKER ALLEGEDLY COULD NOT BE SEEN UNDER ULTRASOUND AND MAMMOGRAM. IT IS UNKNOWN IF ANOTHER MARKER WAS PLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

NO MEDIAL RECORDS AND NO MEDICAL IMAGES WERE PROVIDED TO THE MANUFACTURER. THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. THE DEVICE IS NOT AVAILABLE FOR RETURN. THE INVESTIGATION IS CURRENTLY UNDERWAY. THE INFORMATION PROVIDED BY BARD 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 BARD.

Description of Event or Problem

IT WAS REPORTED THAT POST BREAST TISSUE MARKER PLACEMENT, THE MARKER ALLEGEDLY COULD NOT BE SEEN UNDER ULTRASOUND AND MAMMOGRAM. IT IS UNKNOWN IF ANOTHER MARKER WAS PLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

Additional Manufacturer Narrative

MANUFACTURING REVIEW: AS THE DEVICE LOT NUMBER WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. VISUAL INSPECTION: AS THE DEVICE WAS NOT RETURNED, AN INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: AS THE DEVICE WAS NOT RETURNED, AN EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: AS MEDICAL RECORDS WERE NOT PROVIDED, A REVIEW COULD NOT BE PERFORMED. IMAGE/PHOTO REVIEW: NO MEDICAL IMAGES HAVE BEEN MADE AVAILABLE TO THE MANUFACTURER. CONCLUSION: THE INVESTIGATION IS INCONCLUSIVE, AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. THE DEFINITIVE ROOT CAUSE FOR THE REPORTED VISUALIZATION ISSUES COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE EVENT. LABELING REVIEW: THE CURRENT INSTRUCTIONS FOR USE (IFU) STATES: DESCRIPTION: - THE WIREFORM IS INTENDED FOR LONG-TERM RADIOGRAPHIC MARKING OF THE BIOPSY SITE. THE PELLETS ARE VISIBLE VIA ULTRASOUND FOR APPROXIMATELY 6 WEEKS AND ARE ESSENTIALLY RESORBED IN APPROXIMATELY 12 WEEKS. CONTRAINDICATIONS: - THIS DEVICE IS NOT INTENDED FOR USE EXCEPT AS INDICATED. COMPLICATIONS: - POTENTIAL COMPLICATIONS (E.G. INFECTION) THAT MAY BE ASSOCIATED WITH THE USE OF THE GEL MARK ULTRACOR® ARE SIMILAR TO THOSE ASSOCIATED WITH THE USE OF OTHER BIOPSY MARKING DEVICES. (B)(4). THE INFORMATION PROVIDED BY BARD 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 BARD.

Description of Event or Problem

IT WAS REPORTED THAT POST BREAST TISSUE MARKER PLACEMENT, THE MARKER ALLEGEDLY COULD NOT BE SEEN UNDER ULTRASOUND AND MAMMOGRAM. IT IS UNKNOWN IF ANOTHER MARKER WAS PLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.