It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was to be used in the ureter on a kidney stone holmium laser lithotripsy procedure performed on (b)(6) 2020.According to the complainant, during unpacking, the coil was found detached from the device.Another stone cone was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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It was reported to boston scientific corporation that a stone cone nitinol retrieval coil was to be used in the ureter on a kidney stone holmium laser lithotripsy procedure performed on (b)(6) 2020.According to the complainant, during unpacking, the coil was found detached from the device.Another stone cone was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
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Block e1: initial reporter address: (b)(6).Block h6: device code 2907 captures the reportable event of coil detached.Block h10: visual analysis found the coating on the distal leading tip coming off of the device.The coating was able to be pulled off completely, revealing that the blue outer sheath was extended past the distal stop of the device.The white inner working length also was scratched and had exposed wire near the handle.The blue outer sheath was unable to be moved, however the device was pulled from the distal end to be able to confirm that the coil and its coating were still intact.The instructions for use (ifu) indicates not to exert excessive force when resistance is encountered when attempting to withdraw the coil.Based on all available information, it is most likely that while testing the device before use, excessive force was exerted on the outer sheath, causing it to extend past the distal stop and peel off the coating on the leading tip.Therefore, the most probable root cause is failure to follow instructions, indicating problems traced to the user not following the manufacturer's instructions.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
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