Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one partial senomark marker applicator was returned for evaluation.The marker applicator was returned with the distal end of the applicator detached.One pushpad was returned within the marker applicator and the wireform was not returned.Therefore, the investigation is confirmed for the identified detachment and inconclusive for the reported failure to separate issue.The definitive root cause for the reported failure to separate and identified tip detachment could not be determined based upon the available information.It is unknown whether patient and/or procedural issues contributed to the event.Labeling review: the current senomark breast tissue marker instructions for use (ifu) state: general information and device description: -the marker contains resorbable polyglycolic acid (pga) pads, one polyethylene glycol (peg) push pad, and one titanium or stainless steel wireform.The pads are visible via ultrasound for approximately 3 weeks and are essentially resorbed in approximately 12 weeks.The syringe-like applicator fits within the encor probe to access the biopsy cavity.The pads are deployed from the applicator through the biopsy device into the biopsy cavity.Contraindications: -there are no known contraindications.Warnings: -this device has been designed for single use only.Reuse of this device bears the risk of cross-patient contamination, as medical devices with long and small lumina, joints, and/or crevices between components are difficult or impossible to clean.-do not resterilize.-avoid the use of excessive force during removal of the applicator to prevent breakage of the applicator tip.Precautions: -the device should only be used by physicians trained in percutaneous biopsy procedures.-maintain correct alignment of the yellow indicator key with the red arrow of the biopsy probe when dispending pads.Ensure that all pads are dispensed.Potential complications: potential complications that may be associated with the use of senomark biopsy site marker are similar to those associated with the use of other biopsy marking devices.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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