No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was not provided, a review of the device history records cannot be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event 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.
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Manufacturing review: a complete manufacturing review could not be conducted as the lot number is unknown.Visual inspection: the device was not returned; therefore, a visual inspection could not be performed.Functional/performance evaluation: the device was not returned; therefore, a functional/performance evaluation could not be performed.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the investigation is inconclusive as the sample was not returned for evaluation and images were not provided for review.Per the reported event details, the biopsy clips were visualized under mri imaging.The current ifu states, "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 tissue marker.Therefore, it may be necessary to optimize mr imaging parameters for the presence of this metallic implant." it is possible that procedural issues and/or imaging techniques contributed to the reported events.However, based upon the available information, the definitive root cause is unknown.Labeling review: the current instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.
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