It was reported that following a breast biopsy procedure, a marker was placed and the first mammogram showed the marker in an acceptable position, however the second image showed that the marker had migrated 2 cm away from the biopsy site.There was no patient injury.
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After further clinical review of this event with bard's medical department, this event was reassessed and determined to be mdr reportable as a malfunction pursuant to 21 cfr part 803.A lot history review could not be performed as the lot number is unknown.The marker was not returned for evaluation.Based on the results of the image review, the complaint investigation is inconclusive.Fourteen mammography images were reviewed and no labeling or test annotations identifying anatomical projections or the time the images were taken are displayed on the images.Although a tissue marker is visible in the breast in one image, no comparison between any images can be made.Based on the images provided, marker migration cannot be confirmed.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.
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