Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned and no photos were provided for review.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any deficiency with the needle in respect to the alleged bleeding.Limited information was provided surrounding the event; therefore, a definitive root cause could not be determined based upon available information.It is unknown if patient and/or procedural factors contributed to the reported event.It should be noted that the instructions for use (ifu) provides information to mitigate the risk of product use as well as possible complications.The ifu states: "this product should be used by a physician who is completely familiar with the indications, contraindications, limitations, typical findings and possible side effects of core needle biopsy, in particular, those relating to the specific organ being biopsied." additionally, ¿warnings: good medical judgment should be exercised in considering biopsy on patients who are receiving anticoagulant therapy or who have a bleeding disorder.¿ the ifu further states: "potential complications associated with core biopsy procedures are site specific and include, but are not limited to: hematoma; hemorrhage; infection; adjacent tissue injury; pain; bleeding; hemoptysis; hemothorax; non-target tissue, organ or vessel perforation; pneumothorax; and air embolism.Air embolism is a rare but serious potential complication of lung biopsy procedures.Rapid deterioration of neurological status and/or cardiac arrhythmia may be indicative of air embolism.Prompt diagnosis and treatment must be considered if the patient exhibits signs or symptoms of air embolism." it is unknown if other factors continued to the reported event.Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, cautions, possible complications and contraindications showed that the product labeling is adequate.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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