Block h6: medical device code a0401 captures the reportable event of core wire broken.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the device was found detached with evidence of coil and core wire melted.Also, there was possible to observe the core wire broken and expose.Additionally, the ptfe coating was peeled at the distal section and the urethane section is melted exposing the core wire.No other problems with the device were noted.The reported event was confirmed.During the product analysis, the device was found with the ptfe peeled at the distal section.These failures could have been caused due the interaction of the wire with other devices, the amount of force applied over the device as well as the handling of the device during the procedure.The investigation concluded that adverse event related to procedure is selected as the most probable root cause for the complaint.The device was found with the core wire broken, with the coil wire and core wire and the urethane section melted.It is most likely that the contact between the device and the laser used on the procedure could have contributed with the broken issue observed in the wire, since there was evidence of coil and core wire melted and this type of breakage of the guidewire is consistent with the failure mode of "melted".It is important to mention as a warning use extreme caution when using a laser, making sure to avoid contact with the guidewire.Direct contact may cause damage to the wire and/or sever the wire.Therefore, unintended use error caused or contributed to events is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Block h11: correction to block d4 (model number).
|