H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a bent guidewire was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph of a guidewire.The depicted device was in its plastic hoop.The depicted portion included the distal end of the hoop.The guidewire was visible within the transparent hoop and could be seen to be coiled near the blue cone.While wire deformation was observed within provided photograph, inspection of the photograph was insufficient to identify the cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include attempted insertion against resistance and device manipulation.
|